Sollers College

Tag: Drug Safety and Pharmacovigilance

  • Is pharmacovigilance different now that COVID-19 has been eradicated?

    Is pharmacovigilance different now that COVID-19 has been eradicated?

    When COVID-19 shocked the world in 2020, the importance of drug safety jobs increased. As countries looked for the best way to combat the pandemic, pharmacovigilance also became a hot topic. 

    To determine the best outcomes for COVID patients while attempting to stop the virus in its tracks, the pressure was put on the life sciences market and the industry. Drug interactions and their effects are evaluated, monitored, and discovered in the healthcare system.

    COVID-19 has been devastatingly impacting global health, but the pandemic and its demands have forced the pharmaceutical and pharmaceutical care industries to innovate and develop new methods that can collect and use more reliable and effective data about the safety of drugs.

    The urgent task of gathering and analyzing data from pandemic clinical trials as well as post-marketing settings was suddenly given to pharmacovigilance teams all over the world. Pharmaceutical companies conducted research and innovation at this time to monitor vaccine efficacy and safety. 

    A growing pharmaceutical industry and increased global drug demand are driving up demand for pharmacovigilance experts.

    Many of these innovative techniques improved pharmacovigilance and are now employed to keep track of both newly released medicines and those that have been on the market for some time. Better patient outcomes were the outcome.

    But what exactly are these changes?

    A better way to respond to change before the pandemic, the pharmacovigilance sector was resistant to change. However, the industry had to quickly adapt and think differently due to the urgent need for swift action.

     

    The COVID-19 crisis forced teams in the life sciences to re-evaluate their methods and showed them that change can be a good thing.

    The use of automation and AI tools are being expanded.


    To meet the needs of the healthcare market while ensuring worker safety, many life sciences industries have evaluated and implemented cutting-edge technologies and tools.

    The standards of drug safety procedures have continued to rise, thanks in large part to AI, which at this point became a crutch. The use of AI-enabled chatbots is now being extended to automate more administrative tasks and collect data where human error is unlikely to occur.

    By automating time-consuming intake tasks, this tool allows healthcare professionals to concentrate on the tasks that are most relevant to patients.

    Aside from AI, PV has been altered by:

    • increased drug testing
    • accelerated drug development
    • Effective management and quality control
    • accurate market analysis and forecasting
    • Estimating product costs

    Future developments are anticipated to meet the demand for personalized medicines and therapies as AI’s application to drug safety continues to grow.

    An updated era for tracking adverse reactions


    Before the pandemic, adverse event reporting systems (AERS) were in use. These systems, which are a component of AI technology, became even more important in the effective monitoring of drug safety and public health when the pandemic occurred. To stop misinformation from leading to unnecessary hype and dangerous trends, diligent reporting was required.

    The health industry is now more transparent because of this new era of adverse event reporting, giving patients clearer information about medications and treatments as well as their effects.

     Sollers college is driven to produce results and is enthusiastic about the development of the health and life sciences industry. 

    Our top priority is to find the best candidates for the best PV roles so that the industry can advance. Students can continuously enhance this process to the values and tenacity of Sollers College.

    For career advancement, look through our extensive list of pharmacovigilance positions. Do you wish to learn more? If you need assistance, please get in touch with us.

  • Is pharmacovigilance becoming more of a leadership role in health care?

    Is pharmacovigilance becoming more of a leadership role in health care?

    Pharmacovigilance provides numerous career advancement opportunities in the drug industry. The increased number of drugs and biologics entering the market, as well as the improved drug safety regulatory framework, has increased the demand for skilled resources to carry out PV activities. Because of increased drug safety awareness, rigorous yet cost-effective Pharmacovigilance systems and operations are required. 

    The PV market has recently seen rapid expansion. PV is now well-established as a science in the biopharmaceutical industry. As a result, PV outsourcing has gained traction, resulting in more job opportunities. 

    Both technical and interpersonal abilities are required for any aspiring PV professional. The individual should have a degree in life science, nursing, pharmacy, or a related field. A career in PV is as fulfilling as any other allied healthcare career because the work is so varied. Many pharmaceutical products are collected and analyzed for patient safety.

    PV regulations ensure patient safety in pharmaceutical development and marketing. The pharmacovigilance market demand for direct benefits to manage patient safety is actively growing.
    Hence, a career in Pharmacovigilance can be both rewarding and challenging.

     

    The Industry’s Core Pharmacovigilance Functions and Their Responsibilities

    Along with soft skills, PV is a specialty in the field that calls for specialized knowledge and abilities in pharmacology, PV information sources, critical analysis of biomedical literature, rules, systems, and procedures. 

    The operations typically start with case handling, where reports of adverse events and spontaneous drug reactions from clinical trials are gathered from a variety of sources, including investigation sites, medical staff, patients, publications in the literature, and regulatory agencies.

    Along with these tasks, the PV operations also involve developing and creating countermeasures and risk evaluation and mitigation strategies. The goal of these documents is to ensure the patients’ safety by giving clear instructions on the risks associated with using medications, monitoring them, and taking initiatives to reduce such risks.

    User activities with pharmacovigilance

    Besides its primary duties, the PV department is empowered by management and given support, clinical research, regulatory affairs, healthcare affairs, literature searches, information review, information technology, and assistance, quality assurance, project management, production processes, security of the supply chain, and marketing.

    Since a medical review of the safety data is essential before submission to health authorities, close cooperation between medical affairs and PV is essential. This guarantees that a suitable company comment is given to the ICSRs and that periodic safety reports are reviewed.

    The compliance and training group is another interface function that closely collaborates with PV. This group is crucial to the operation of a Pharmacovigilance system because it makes sure the business complies with all laws and regulations about its PV obligations as well as by giving human resources working in various PV functions the necessary training and exposure. 

    The compliance teams assist PV with quality assurance, including audits and inspections. Employees in the compliance and training groups must be knowledgeable in the field of PV.

    PV focuses on the pharmaceutical sector

    In the pharma sector, PV as a discipline is now well-established. When conducting PV activities, an organization must have access to a great deal of skilled, suitably qualified, and trained personnel to produce the desired quality results. This makes it easier to derive a meaningful conclusion from the data and then submit it in a predetermined format for reporting purposes.

    Pharmacovigilance: career-enhancing abilities

    For a PV career to be successful, it requires a mix of both soft skills and technical skills. Organizations have formed hiring strategies for various PV roles and responsibilities, and such plans necessitate that the candidates fulfill these prerequisites.

    With more roles, there are more requirements. The requirements can be broadly divided into three groups:

    1) Technical expertise

    Aspiring PV professionals must be familiar with the fundamentals of pharmaceuticals, healthcare, ADR, EU, and GPP. Although candidates with a life sciences degree can obtain an entry-level position in PV, there is generally a preference for healthcare professionals in the pharmaceutical industry. 

    Graduates in life sciences can apply for a PV position. Dentistry, nursing, pharmacy, and life sciences are among the academic specialties represented among the staff members of the current PV organizations. The PV organizations primarily hire graduates with healthcare degrees in medicine or pharmacy.

    2) Skillsets

    Along with the necessary technical skills, specific soft skills are crucial to one’s employability in the PV industry. Qualified candidates for any PV role must demonstrate skill competencies to support their technical knowledge during the interview process.

    1. Acquiring the necessary skills to advance your career

    A successful career progression also depends on ongoing learning and development while working, in addition to the technical and soft skills mentioned above. Professionals who possess these skills are better able to learn beyond the curriculum content and are constantly on the lookout for innovative concepts and cutting-edge technology. Through practice and self-motivation, these abilities are easily learned and acquired.

    Synopsis

    For graduates and postgraduates in medicine, pharmacy, and the life sciences, the industry currently offers a wide range of opportunities in PV. Because the work entails gathering and analyzing safety data for many medications aimed at patient safety, a career in PV is equally as fulfilling as any other allied healthcare career. 

    Candidates interested in pursuing careers in PV should be passionate about their work because it will have an impact on society. In the labor market, there will be a persistent need for qualified PV personnel.

    For successful career development, jobs in the industry would need both technical and soft skills. Once employed as a PV, there are many opportunities for career development through ongoing education and training.

     Pharma companies can take advantage of the opportunities. Continuous self-development is the key to career advancement in the PV sector.

     PV professionals should investigate opportunities for lateral and vertical growth, enrichment, realignment, and transition if they want to have a successful career in the sector.

     

    It is now possible at Sollers college to learn how to effectively master the fundamentals of action potential in just one place so that you can soar to ever-greater heights as you strive to reach ever-higher levels. 

    Create a pathway and learn in multiple ways and don’t hold yourself back. Boost your professional life by optimizing it and reaping the rewards!

  • What are the six most influential factors in pharmacovigilance?

    What are the six most influential factors in pharmacovigilance?

    The development of new pharmaceutical products is heavily reliant on pharmacovigilance. It guarantees that these goods are used safely and efficiently to improve patients’ health. Due to increasingly strict rules and the growing significance of patient-centricity, pharmacovigilance is now much more important than it was formerly. The industry’s current pharmacovigilance trends are outlined in detail.

    1. Driving efficiency and profitability through procuring

    Pharmacovigilance-specific outsourcing is becoming increasingly popular as a means of coping with the rising cost of keeping an internal workforce that is highly skilled and trained.

    An effective pharmacovigilance outsourcing program has measurable advantages for manufacturers and sponsors. Businesses nowadays outsource their pharmacovigilance work to improve regulatory compliance, quality, productivity, and strategic decisions. 

    1. Early assessment of safety concerns using qualitative and quantitative data 

    Secondary data sources have multiplied over the past few years and at this time includes:

    Social networking, computerized medical records, and claims files. Regulatory reports and documents filed by various authorities. 

    The gathering and integration of secondary data sources with traditional datasets present special difficulties. From a regulatory standpoint, pharmaceutical companies are now just at the beginning stages of their use of secondary data.

    However, initiatives like the Sentinel Initiative of the FDA and WEB-RADR of the EMA demonstrate the interest that regulatory bodies have in the utilization of secondary data.

    Technology vendors have recently begun to provide reliable and adaptable systems that aid life sciences organizations in handling and integrating a variety of file kinds and integrating social media streams into their pharmacovigilance operations.

    Social media streams are being added to the scope of sophisticated algorithms and disproportionality analysis, in addition to conventional spontaneous reporting.

    The combination of secondary data sources and cutting-edge signal detection technologies enables the quicker identification of safety issues and the implementation of risk reduction measures.

    1. Cloud-based Data to Create a Powerful Global Adverse Event Network 

    Massive volumes of data can now be stored and analyzed in the cloud, which is advantageous for many sectors. Life sciences organizations must optimize the intake, storage, and analysis of large volumes of data as the number of data sources increases.

    Moving to the cloud is primarily motivated by:

    Cost-effectiveness: Using the cloud may allow businesses to deal with a large volume of case data while maintaining quality, security, and data privacy. 

    Scalability: The volume of adverse event cases for life science firms has been increasing rapidly, with some firms reporting a yearly increase. This increase necessitates the use of equipment that can easily handle the growing volume of data.

    By letting firms avoid concerns about module compatibility and server scale, cloud utilization can make life simpler for them.

    1. Protection and assimilation of vast amounts of information using big data

    In recent times, pharmacovigilance specialists have gained access to new digital sources of experimental data and real-world evidence.

    Big data sources used in pharmacovigilance include:

    Signal identification; confirmation and substantiation of safety signals for drugs or vaccines; online channels and social media. 

    Because of its complexity, big data represents both a challenge and an opportunity. Life sciences firms employ big data to better effectively monitor and research drug safety thanks to technological advancements with high-end computer capabilities.

    1. Data Analytics to Drive Useful Understanding


    For a comprehensive knowledge of safety occurrences, it is essential to handle safety data collected across numerous platforms effectively. A rising number of life sciences organizations use cutting-edge pharmacovigilance techniques to analyze vast and diverse data sets, including safety information. To safeguard the safety of their patients more effectively, they work to identify novel patterns, unrecognized correlations, trends, and patient preferences.

    These days, pharmacovigilance analytics offers a real chance to successfully harness data, assure regulatory compliance, and generate useful insights.

    1. Streamlining Non-Value-Adding Activities in Pharmacovigilance Functions

    Companies in the life sciences industry are actively seeking solutions to cut down on the rising cost of pharmacovigilance and the likelihood of human mistakes in pharmacovigilance jobs. Automation is a key component that can assist companies in achieving both objectives by:

    Streamlining the entire safety procedure

    removing unnecessary steps from the existing procedure

    improving team productivity.

    Life sciences organizations have an increasing number of opportunities to incorporate automation into their routine pharmacovigilance activities as regulatory bodies roll out new tools to gather and analyze adverse occurrences.

    Sollers College will assist you at every step of the journey. We are your first point of contact for any support you may require. Sollers gives you any information you need about your career.

  • Drug safety case processing: key issues and strategies to prevent them

    Drug safety case processing: key issues and strategies to prevent them

    Case processing is one of the most crucial aspects of drug safety. It provides data for the analysis of side effects, enabling us to identify newly emerging safety concerns and regularly assess the balance between the risks and benefits of using a pharmacological treatment.

    Safety data processing must be exact and of a high standard from a medical and scientific perspective to give accurate analysis and prompt corrective action, which in turn serves to safeguard the health of the patients and make it possible for the safe use of the drug.

    Why is it so important to ensure the highest degree of case processing quality?

    Case processing, a crucial pharmacovigilance activity, enables the transmission of substantial volumes of safety data across numerous stakeholders, such as patients, physicians, and responsible authorities. Processing a case involves the following steps:

    Case report presentation

    • Prioritization of case reports: duplicate check validation
    • Transmission of a medical evaluation to partners: quality assurance closure for data entry for archiving.
    • When processing cases, it is crucial to ensure the quality of the data.
    • Effective data analysis, scientific evaluation, and decision-making are dependent on the proper handling of case processing tasks, which in turn enables effective public health protection.
    • Observing regulations: To effectively protect the health of patients, safety data must be properly analyzed and used for benefit/risk evaluation and signal detection activities.

    Case processing common mistakes:

    Numerous quality problems are encountered by pharmacovigilance staff members who handle case processing activities. The most typical problem is:

    1. Insufficient reporting

    Contradictory data and coding errors signify an incomplete or inconsistent medical assessment.

    2. Incomplete report mistake 

    The most efficient way to deal with the issue of incomplete data is through routine training. 

    The quality assurance AE/SAE report is also included.

    3. Incorrect coding

    • The most important role of medical coding is to standardize and group disparate phrases into a standard parent category, which is necessary for efficient safety data analysis.
    • Medical coding is crucial for preventing spelling errors, inaccurate abbreviations, or non-standardized terms.
    • Coding mistakes can be avoided with a suitable and transparent source of data. Pharmacovigilance experts, however, occasionally get acronyms and information that are incorrect or unclear.
    • Congestion, of which the type (pulmonary, nasal, hepatic, sinus, etc.) is unclear,
    • Uncertainty about the sort of pain
    • Myocardial infarction (MI) or mitral incompetence (MI) are the two terms that are not entirely clear.
    • It is recommended to speak with the reporter personally to get clarification in such circumstances. The use of lower-level terminology might be permissible if the clarifications weren’t thorough.
    • If the clarifications are not exhaustive, lower-level terminology (LLT) should be used. The “MedDRA Points to Consider” page is also beneficial to review because it has a wealth of examples organized by type of coding issue.

    Narrative

    When crucial details from the case narrative are missing from the structured fields, it is a common type of error for the narrative to be incorrect.

    All information in the narrative must be accurately documented in the pertinent structured fields for pharmacovigilance professionals to promptly examine the cases and enable reliable data retrieval.

    How to Process a Quality Case

    Case processing is an essential task that forms the basis of pharmacovigilance decision-making. It enables the pharmacovigilance team to accurately analyze the safety data and take remedial actions promptly, ensuring that the drug benefits the patients in the best way possible.

    There are many strategies that can help to raise the standard of case processing, including:

    • Employees in clinical development, sales, medical information, legal, and quality control may require additional training.
    • Safety data collection forms that are easy to read and well-designed.
    • Random samples of patients are periodically examined.
    • All data entered into the database is subjected to quality control by a second individual.
    • Regular checking of a sample of instances taken randomly from the database. This can either be a thorough check or a check of the essential fields you’ve chosen.
    • Checking for deviations in KPIs and CAPAs.

                                                      Get the right chance to succeed in society and change things.

     A career in drug safety and pharmacovigilance affords you the chance to make a difference in people’s lives because of the recent increase in demand for pharmaceutical and drug safety specialists.

    Accredited courses in drug safety and pharmacovigilance are available at Sollers College.

  • Could Analytics and Technology Change Pharmacovigilance?

    Could Analytics and Technology Change Pharmacovigilance?

    Pharmaceutical companies utilize pharmacovigilance techniques and procedures to make sure the products in their portfolio meet the necessary safety requirements. PV is the practice of monitoring a drug’s outcomes after discovering unreported adverse effects.

    This can help pharmaceutical firms get innovative insights from safety data to reduce PV costs, improve the efficacy of their products, and discover novel treatment options like the three-point seatbelt, which may be beneficial to their company, the pharma sector, and society.

    The pharmaceutical industry’s top concerns are the efficacy of its products and the security of its customers. Several businesses are advancing PV by making modest investments in process automation.

    Automation could be used for case processing and signaling.

    • Multiple markets and industry trends are putting current PV systems and processes to the test, forcing some pharmaceutical organizations to consider more efficient and cost-effective ways to gather trustworthy safety data and high-quality information.
    • Some survey respondents claimed to be using automation to reduce the cost of case processing and improve signaling.

    Case processing

    • The primary goal is to lower the expense of case processing. The cost of PV varies depending on the processing of each case. Additionally, there are more cases every year. Some manufacturers are actively exploring automation of case processing while using scale and outsourcing. For each case safety report, automation may result in annual cost savings.
    • To increase patient safety, maintain compliance, and achieve cost control over case processing, a corporation must be able to automate more of these operations.
    • Automation investments have a considerable positive impact on case processing teams’ productivity. Productivity boosters are native automation and “bolt-on” solutions that can lessen the work needed to run duplicate checks, speed up coding tasks, and expedite narrative authoring.
    • The capacity to automate complete case-processing processes, however, is restricted. Even for relatively basic instances, end-to-end case automation is still a long way from being a practical production capability.
    • Short-term signaling investments are anticipated to concentrate on visualization, and longer-term efforts are linked to data integration as well as tool and process enhancements as pharmaceutical companies work toward genuine safety management. 
    • Due to limitations in the signal detection and management systems currently in use, safety information to tie back into the discovery process is still lacking. The ability to detect signals is improved by higher data consistency and quality. Predictive signaling is the ultimate objective.

    Automation action

    The study will also demonstrate that even bigger gains are feasible by developing the technology and analytics necessary to build a PV system that focuses on benefit-risk management and proactive monitoring over the whole product lifecycle. This strategy will be advantageous to pharmaceutical firms, the life sciences sector, and society at large, like the three-point seatbelt.

    The development of a future PV system to increase patient safety

    • PV budgets for biopharma firms must include funds for automation, cognitive technologies, and analytic tools to lower case processing costs, enhance signal processing capabilities, and speed up product safety reports.
    • It is possible to build a true, evidence-based hub for safety intelligence throughout the whole product life cycle and to fully understand the benefits and risks of a product by adopting a proactive, patient-centered mindset. Several internal PV groups access safety information from external sources.
    • The function of signaling is to implement a modular learning loop system that makes use of automation and cognitive processing to employ continuous learning to help limit risk and increase compliance.
    • Systems should be equipped with cognitive case processing capabilities that automate data collection and processing to greatly increase the efficiency and calibre of the AE life cycle.
    • For analysts to perform validation and assessment tasks, collect results, and mark signals without leaving the system, signal detection, evaluation, and management that consolidate and streamline processes and systems are needed. As a result, signal handling is more precise and better.
    • Safety metrics that make use of current safety data, fresh real-world sources, supervised and unsupervised machine learning, detection, assessment, and prevention of safety-related problems while revealing advantages that can enhance patient outcomes.

    PV System to Increase Patient Security

    PV operations will change because of the adoption of advanced learning, which will improve decision-making through expanded data cohorts and cognitive innovation.

    Cognitive case processing insights enable intelligent, efficient signaling and aggregate reporting.

    • Enhancements to case quality and compliance
    • Targeted human reviews by bright and perceptive individuals that increase insights and expertise
    • Increased value-based resource allocation

    Case processing and signaling automation are influenced by the lessons learned from the case series evaluations.

    • It produces aggregated report content automatically, with analysis and benefit-risk insights.
    • Automation, uniform analysis, and evaluation of safety results are made possible by a single data universe.
    • Aggregate reporting becomes a process under the direction of professional review.

    Utilizing the knowledge and insights acquired from signaling detections and reviews, case processing and aggregate reporting are automated.

    • Encourage automation and intelligence in the signal management process.
    • Review and judge signals automatically based on patterns and trends and offer benefits and risks proactively to the scientists.
    • Make use of other data sources, including clinical safety.

    Sollers College provides professionals who wish to follow training regarding a career path in pharmacovigilance.

    You may close the skills gap between these attractive occupations and what potential candidates are looking for. 

    Every career has a path and, nowadays, benefits from additional help.

  • Digitalization opens new opportunities for pharmacovigilance

    Digitalization opens new opportunities for pharmacovigilance

    Due to continuously expanding market and regulatory constraints, industries have been forced to re-evaluate their safety operations and how they affect operating costs, productivity, quality, audit, and compliance.

    Pharmacovigilance must be integrated into a pharmaceutical company’s daily operations for it to be effective. Pharma businesses revolutionize the entire PV process by leveraging technology. Automation is the initial stage in the transition of PV.

    Document Intelligence

    • Pharmacovigilance activities access a huge amount of varied, dynamic, dispersed, structured, or unstructured data, which presents hurdles in terms of its interpretation due to its complexity, content, and scale.
    • Traditional methods are frequently insufficient for processing the volume of data that is so huge and complex since no actions can be taken on the gathered data without a structured generated document.
    •   Artificial intelligence technology with smart documents and reporting capabilities could be a potential answer to all of this. Such solutions can assist PV professionals in creating templates and streamlining the material so that, when necessary, the necessary data can be fetched in only a few seconds.
    •  It helps to produce data-driven documents because it can process several data sources at once. These systems require fewer people to pull data each day because they have the functionality to interact directly with data sources. It is easier to evaluate the data as and when needed by creating templates that are appropriate to the data and needs.
    •  Conventional data sources have been used as the main data sources for gathering patient safety information on pharmaceuticals and clinical trial outputs. However, none of these by themselves can be used to establish the full safety profile of a product.
    •  Entering the world of big data and concrete proof is therefore vital. By incorporating numerous social media platforms, claims data, electronic health records, wearable platforms, and more, it has greatly increased the number of data sources.
    • Although these new data sources offer helpful information for recognizing safety signals, it takes a lot of effort to process the vast amount of data they produce.
    •  According to the FDA, only the highest quality data should be evaluated and reported. PV professionals may develop reports that are specific to a certain market niche because of the smart document flexibility of AI platforms.
    • Based on conditional logic built right into the document design, they can choose to display or conceal the data. As a result, it takes less effort and money to provide customized and segmented reports.
    • Therefore, the digital revolution brought about increased computer skills that sparked the attention of regulatory agencies, pharmaceutical companies, and researchers in using big data for monitoring medication safety and smart capabilities for creating papers and reports.

    Document Digitization in Pharmacovigilance

    • Document digitization is the first benefit of automation in the PV industry. According to statistics provided by the WHO, drug side effects are the fifth most common cause of mortality. Therefore, pharmacovigilance is essential because modern patients eagerly anticipate learning more about the safety of drugs and treatments.
    •  Companies are required to consider the information on AE from numerous data sources, including chatbots, public forums, social media, and other channels, following the new legal standards.
    • The number of data streams has significantly increased because of this need, which has inevitably resulted in a rise in the amount of data being transmitted.
    • The range of adverse event data and the requirement for analysis have led to a complicated PV process. Separating genuine crisis cases from alerts takes a lot of time amidst the data flow.
    • Pharmaceutical companies must meet regulatory requirements for the integration and management of enormous amounts of data that are used for the evaluation and processing of drug safety information, in addition to the pressure brought on by the market’s production of data.
    • For stakeholders in the pharmaceutical industry to meet these standards, document automation systems must undergo significant modifications.
    •   The document automation system not only speeds up the documentation process but also enables PV specialists to create visually appealing documents that incorporate all the data logic directly into the template.
    •  Adverse events spiral out of control because of the slowdown in signal detection. Document automation is the only way for organizations to efficiently handle such a massive collection of data.

    Automation for Analyzing Adverse Outcomes

    • Adverse event processing is the main objective when it comes to automating PV operations. Pharmaceutical industries spend a significant amount of time, money, resources, and effort to carry out this repetitious procedure properly.
    • The case management procedure in PV is already largely automated. When compared to manual submission of forms, this has increased the quality of submissions. Additionally, electronic submissions happen on their own and don’t affect the schedules for regulatory reporting. Therefore, the impact of AI applications in PV on the effectiveness and efficiency of the work is also anticipated.
    •  The degree of automation in case processing depends on a variety of factors, including the volume of cases, the number of phases in the case processing workflow, and more. This renders some of the manual processes unnecessary.
    •  AI can be used to make the case intake process even simpler. This can make use of both machine learning (ML) and natural language processing (NLP) ideas.  

    Cloud-Based Pharmacovigilance Solutions

    • By keeping a sizable amount of data in the cloud, numerous sectors have profited. The pharmaceutical sector has experienced a boom because of the necessity to maximize data intake, store it, and then analyze it.
    • An expanding number of data sources are now adding to our understanding of the advantages and risks of pharmaceutical goods.
    •  Big data applications for pharmacovigilance have become relevant with the rise of cloud technology. Pharmaceutical businesses will need technologies that are effective to handle the enormous number and diverse data sources surrounding adverse drug reactions to make educated decisions in PV.
    • To provide regulators and those in possession of marketing authorizations with knowledge and valuable information, big data output must be integrated and unified. At the patient or public health level, it can aid in the prevention of severe ADRs.
    • With the help of this large amount of data, the owners of marketing authorizations can defend the market position of their medications.
    • Pharmacovigilance software suppliers are anticipating being able to offer extremely customized and durable solutions that guarantee data security. Users may easily employ signal detection and data analysis approaches as more and more pharmacovigilance data is moved to the cloud to be evaluated.
    • Additionally, the ability to always access the most recent version of pharmacovigilance software without the need for in-house installation will contribute to its wider acceptance.

    Results and Discussion

    • Due to document automation, artificial intelligence, and cloud technologies, pharmacovigilance tasks have already undergone a major revolution.
    • Each new generation of instruments will also improve intelligence and adaptability, expanding the scope of applications to creatively tackle fresh pharmaceutical challenges.
    • The regulatory bodies and the pharmacovigilance firms are aware of the potential for PV with these technologies.
    • Some pharmacovigilance procedures, such as case entry, case processing, and reporting activities, are automated using modern technology.
    • Individual case safety reports (ICSR) can be less time and money-consuming for businesses, freeing up resources for proactive risk assessment, identification, and mitigation.
    •   By implementing technologies like document automation, AI, and cloud-based solutions, pharmaceutical companies can advance toward end-to-end automation across the PV spectrum.

    Students at Sollers College receive education about the regulatory roles that pharmacovigilance plays and how those roles are operationalized.

    Students are equipped with the fundamental knowledge and practical skills needed to meet the demands of the expanding healthcare industry.

     By gaining knowledge of the necessary abilities, you can build a fulfilling profession. Your learning is aided by an all-encompassing program that is in line with Soller’s College. 

     No prior experience? No worries! Participate right away.

  • The Current Pharmacovigilance System Goals

    The Current Pharmacovigilance System Goals

    • Due to increased concerns about pharmacovigilance, PV has become more crucial in the pharmaceutical industry.
    •  PV, according to the World Health Organization, is the science and methods involved in the ongoing detection, evaluation, and comprehension of adverse events or adverse medication reactions to determine the risk profile of a product.
    •  A primary national regulatory authority and numerous regional or national centers make up the common structure for a national pharmacovigilance system.
    •  According to WHO, National Centers are pharmacovigilance facilities authorized by the organization that are in nations taking part in the WHO Programme for International Drug Monitoring.
    •  Typically, NCs are affiliated with or a component of the national drug regulatory body. Individual case safety reports are sent to a local PV center by healthcare professionals and patients.
    • The drug safety sector is currently under pressure from expanding data quantities and complexity to find solutions that lower case processing costs while maintaining compliance with globally changing standards and preserving or even improving the information quality in ICSRs
    • In parallel to this, regulatory organizations are pressuring doctors to record more instances of PV, and patients are also sharing their accounts of adverse events. 
    •  This entails making use of outsourcing partners’ advantages, which help manage workload demands and limit workforce expansion while delivering scalability. Although the opportunity for outsourcing is limited, the processing still requires manual labor.
    •  Pharmacovigilance is a post-marketing tool that guarantees a drug’s safety. The detection of ADRs and the mitigation of related hazards are its main concerns. Regarding tiers of the social healthcare setting, a well-structured PV system can assist in producing correct safety data.
    • A well-thought-out plan that guarantees flawless execution and tangible benefits is required for the establishment of a pharmacovigilance system.   

    Current Pharmacovigilance Challenges

    PV systems have come a long way over the past few decades, but they still face several obstacles today. A well-designed PV system can assist in accurately generating safety data for several spheres of the social healthcare setting. The establishment of a pharmacovigilance system necessitates the harmonization of several criteria and a carefully thought-out strategy that guarantees flawless execution and physical benefits.

    The Current Pharmacovigilance System Goals

    Situation 1: Inconsistent reporting of adverse events

    • Adverse events, however, do not always occur while visiting the healthcare center. It can happen several hours after the medicine was administered. Patients frequently struggle to appropriately report AEs since they can’t recall every detail about them.
    • When a patient disregards medical advice or experiences negative effects from drugs taken simultaneously with prescribed therapies, this is referred to as an adverse event. Such inaccurate reporting may cause drug safety committees to draw erroneous conclusions, which may result in the suspension or removal of medications.

    Situation 2: Constantly changing laws and business practices

    •   PV systems must scale easily and effectively because of business expansion into newer markets. It has become crucial to ensure that PV systems and procedures continue to advance.
    •   The underlying database, configurability, reporting capacity, and system connection with data sources and other applications are just a few areas where the evolving regulations have an impact on PV operations.
    • Regulation non-compliance and the resulting fines are caused by a lack of support and continually evolving standards. The need varies more widely in non-ICH regions, making reporting even more challenging.

    Situation 3: Data Processing and Detection

    • Because of the steadily increasing amounts of AE data, it is difficult for reviewers to track, identify, and manage all potential developing patterns using only qualitative methods. Since manual processes take a long time, it can take the reviewer a few weeks to study a particular signal.
    •   On the other hand, the regulators’ and life science enterprises’ query and response cycles are rapidly closing, forcing the reviewers to quickly assess the signals.
    • Reviewers must concentrate on current problems while spending less time and effort identifying false signals. Ineffective signal detection and handling make it difficult to meet regulatory reporting requirements, which results in fines.

    Situation 4: Operational efficiency and productivity

    • When transferring and submitting cases across ICH areas, an organization faces many challenges. Some businesses choose to send the submission data back to their main office to keep the central system up-to-date.
    • Routing and maintaining track of ICSRs must be done manually because pharmacovigilance is not automated. The procedure is delayed as a result, and AE processing and reporting are inadequate.

    Situation 5: System Implementation

    • Existing PV systems have problems with system integration, data sharing between unrelated applications, system availability, and system scalability. It leads to a system breakdown because of poor scaling and shaky performance.
    • Data inconsistency results from the manual intervention involved in this. As a result, productivity and efficiency suffer in PV departments.

    Situation 6: Handling a larger volume of data

    • v  Processing the growing amount of data that the ecosystem is producing is posing a serious issue for the worldwide PV business.
    • v  An annual exponential increase in data quantities is being caused by a variety of sources, including journals, publications, social media, patents, and an increasing number of unstandardized data sources.
    • v  However, many businesses continue to manage information using outdated technological platforms and manual procedures. This reduces productivity and is prone to mistakes.

    Situation 7: Ensuring Data Quality

    • The complexity and variety of the technologies used to gather and store the data are growing along with the volume and type of data being collected during the life cycle of the product.
    •  Certain data input and data coding standards are essential for accurate reports and signal detection.
    •  To maintain quality, newly entered or received data must be reviewed for quality.
    • A PV system should adhere to certain specific parameters to reduce errors in signal detection, recorded data, and aggregate reporting.

    ‍ Join Sollers College today to start your career in drug safety and pharmacovigilance. Your PV skills will be helped at every stage of the curriculum. Students who are ready to develop their profiles can choose from training programs offered by Sollers.

    Sollers’ College distinctive curriculum consistently creates a wide range of career options and offers the best professional supervision and swift learning support.

    To learn and share your knowledge, Sollers College created a road to the sizable pharmaceutical sector. Don’t let yourself be limited to meeting your needs in this pharmaceutical market.

  • The Outcomes of Automation on Pharmacovigilance in the Real World

    The Outcomes of Automation on Pharmacovigilance in the Real World

    • Pharmacovigilance’s main objective is to encourage the safest possible use of medications. However, it is under greater pressure to quickly analyze additional data, monitor risks more thoroughly, and accurately report patient occurrences on a worldwide scale. Pharmacovigilance is a field that has experienced rapid expansion in recent years.
    • Traditional PV plans must be changed and revitalized with smarter expenditure in mind due to the constant challenges of cost optimization. Instead of concentrating exclusively on safety operations, attention is being paid to proactive risk management, individualized treatment, and comprehensive data transparency between pharmaceutical companies, patients, healthcare providers, and regulatory bodies.
    • Pharmaceutical PV strategy updates are largely influenced by technological advancements. For instance, more businesses see big data analytics, robotic automation, cloud-based solutions, and mobile applications as essential components of clinical, safety, and regulatory operations in the pharmaceutical sector. To effectively manage the safety of pharmaceutical products, it is becoming increasingly essential to implement cutting-edge technological automation tools and processes for PV methods.

    Enhancing Functionality

    • PV techniques must be optimized for maximum efficiency because they are one of the life sciences fields with the fastest growth.
    •  A solid foundational framework for IT gives organizations great performance, scalability, system validation, and data security for efficient design and dissemination of automation efforts.
    • Operational efficiency can be increased, and a proactive PV strategy can be driven by taking care of organizational needs, process improvements, and IT solution enhancements concurrently.
    • Traditional PV systems now have holes that AI has the potential to fill, such as the need to map patterns and integrate massive amounts of cloud-based data to accurately predict ADRs. This more streamlined strategy can also use genetic data and actual patient data to make PV a more predictive science.
    • Integrated IT solutions that integrate technical and scientific know-how can produce high levels of operational effectiveness, quality, and regulatory compliance.

    A Four-Stage Automation Approach

    •  Even though many of today’s IT systems and apps are capable of automating case processing and reporting tasks, the total process still necessitates a sizable amount of manual labor, especially when it comes to case intake and data entry.
    •  Many levels of automation can be used to streamline end-to-end safety processes and eliminate unnecessary, non-value-added steps in existing processes while boosting the effectiveness of human labor.
    • Basic process automation, which includes task tracking and monitoring and enables the gathering of continuous metrics, is the initial stage. The entry, processing, and analysis of safety data into a database or system still require manual labor.
    • Basic automation offers reporting and dashboards and automates a workflow involving numerous roles. The next stage, robotic process automation, assists in reducing or removing these manual processes.
    •  Robotic Process Automation is frequently paired with cognitive automation, the next level after RPA that uses Natural Language Processing (NLP) to support human decision-making.
    •  The system interacts with people, but the ultimate level, AI, requires little to no human interaction and self-learns via experience to generate predictions based on patterns found in massive amounts of data with the use of machine learning.

    Regulations adapted to industrialization

    • The development and application of technologies that can provide a safe, integrated big data repository are desperately required due to the ever-increasing volumes of drug data. As a result of a major development in the PV industry, cloud-based capture and reporting and a fully integrated database are accessible to all stakeholders.
    •  Cloud technology integration can improve data collection, storage, and analysis even further and potentially offer geographical and temporal insights into ADR patterns.

    Implementing a strategy for automation

    • Higher levels of automation, like RPA and cognitive automation, allow businesses to identify patterns in unstructured data and can automate the entire procedure, from case receipt through reporting.
    •  Implementing an automated plan can enhance the precision and quality of secure data processing by removing the possibility of human error, in addition to lowering expenses.

    Integrated PV processes’ outlook

    • Regulatory authorities adopt more sophisticated methods to gather, characterize, and assess data on AEs because of the evolving PV landscape, enabling pharmaceutical companies to build effective PV programs and more effectively control the safety of their products.
    •  The industry is undergoing a technology revolution, driven in part by an expanding population, an increase in novel and highly specialized remedies for unmet medical needs, and an increase in the number of pharmaceutical organizations.
    •   Automation is essential if clinical trial costs and complexity are to be kept to a minimum and stakeholder engagement for real-time decision-making is to be enhanced.

    One can start a profession in Pharmacovigilance right now. Upskill with excellent learning to kickstart your career in this PV field. Build a rewarding career by learning industry-relevant skills.

  • Fundamental Updates on Pharmacovigilance-Technology, Analytics, and Automation

    Fundamental Updates on Pharmacovigilance-Technology, Analytics, and Automation

    Pharmacovigilance systems are now being changed by developments in health care, such as complicated international legislation, an increase in the volume of adverse effects, and new data sources. Analytics, automation, and cognitive technologies offer the potential to refocus the pharmacovigilance role from collecting and reporting data enhancing product quality, and treatment regimens, lowering costs, and enhancing patient safety.

    Outlook on the expanding pharmacovigilance

    • The pharmacovigilance function has overseen the gathering, processing, and informing regulators of adverse events and other product safety data for several decades. Because PV is a process-intensive technology, corporations frequently choose the safety systems that go with it based on how well they can organize data and maximize efficiency, which leaves them with few options.
    • Numerous worldwide health care developments are reshaping the PV function of today. While many of these changes offer significant advantages, they are also putting pressure on the safety measures now in place in biopharmaceutical businesses.
    • Many organizations are dealing with sizable financial burdens to maintain and upgrade these systems even though, according to the current safety system paradigm, the same trends may cause the costs of conventional upgrade approaches to increase at a rate that is out of proportion to the benefits. As a result, many biopharma companies are starting to think about how automation, cognitive technologies, and advanced analytics may help them get more out of their PV systems.
    • They are moving past the point where they are merely analyzing, formatting, and submitting patient reports and provider-supplied case processing and signaling data to the point where they are developing a next-generation digital learning system that effectively and affordably improves product quality and patient safety.

    Focus long term: Case assessment and reporting

    Case processing: With case volumes increasing gradually every year and PV budgets spending expenditure on case processing, bringing down costs is the top priority for survey participants. Low-cost leaders are outsourcing, utilizing scale, and accelerating the automation of case processing.

    Signaling: Most pharmaceutical companies still rely on established signal detection and investigation techniques. A small number are utilizing real-world evidence, and almost none are advancing social media channels. This is compatible with the capability of modern PV systems.

    Wide-ranging chances to increase signal processing and inquiry maturity are seen by survey respondents; half of them.

    Most respondents indicate they intend to increase their signal processing and investigation competence because they perceive the significant potential for improvement. Predictive signaling is the ultimate objective.

    Developing a next-generation PV system to increase patient safety

    Automation, cognitive technologies, and sophisticated analytics should all be included in PV budgets for biopharma businesses for the following reasons: decreasing case processing costs, enhancing signal processing capabilities, and speeding up product safety reports. But if biopharma uses digital technology to develop a subsequent-generation PV learning system for increased patient safety, we expect even greater advantages.

    A shift to a proactive, patient-centered strategy can make it possible to have a true, evidence-based center for safety intelligence throughout the whole product life cycle and to have a thorough understanding of product benefit-risk profiles.

    To process safety data, pharmaceutical companies currently use a few siloed information systems, which may hinder many of them from achieving the anticipated future state. For instance, different internal PV groups assess safety data obtained from external sources in diverse ways and for varied goals; each group may gather and analyze data from as many as a dozen different systems, leading, unsurprisingly, to the production of many versions of the truth.

    Implementing an end-to-end, modular “learning loop” system that uses a unified data platform and automation to cognitively process upstream and downstream safety information and leverage continuous learning to help mitigate risk, strengthen compliance, and improve patient outcomes is one way to break the case processing cost curve while also enhancing the role of signaling.

    Enhancing pharmacovigilance automation

    To ensure patient safety, all people concerned with drug development are accountable. Automation, smart technologies, and advanced analytics are opening possibilities for pharmacovigilance to change from the process of writing AE reports for regulators to creating a learning system that prioritizes benefit and risk management as well as proactive surveillance throughout the product life cycle.

    PV organizations should first consider their future goals and decide whether achieving them will require gradual or radical change.

    Sollers college offers short and long-term programs in Drug Safety and Pharmacovigilance. These job -oriented programs open a wide range of career opportunities in the pharmaceutical industry.

  • Discover the Key to Smart Pharmacovigilance

    Discover the Key to Smart Pharmacovigilance

    Today’s PV function has evolved into a corporate asset that boosts brand value and creates new growth opportunities because of various trends in global healthcare. However, maintaining the current safety systems is quite expensive.

    Pharmaceutical and biopharmaceutical businesses are under intense pressure to reduce case processing costs while maintaining high regulatory compliance and raising the safety profile of their products through proactive signal identification.

    Regulatory requirements force pharmaceutical and biopharma businesses to create a pharmacovigilance/drug safety surveillance program and keep an eye on the safety profiles of their marketed products during the whole product lifetime.

    To facilitate proactive identification and prediction of safety signals and benefit-risk evaluation for marketed medicines, businesses are increasingly focusing on reorganizing drug safety and risk management programs. These organizations are also combining data sets across all stakeholders (pharmaceutical companies, regulatory authorities, patients) to foster complete transparency, sharing, and partnership. 

    The industry processes and notifies local regulatory authorities of adverse occurrences using a variety of safety databases, such as Oracle Argus, ARIS-G, etc.

    Transformation to smart case processing is required

    1. The need for pharmaceutical companies to deploy and maintain more complex PV systems and manage safety surveillance activities is growing because of the changing regulatory environment and increased regulatory scrutiny, increasing disease complexity and the number of drugs getting approved, and growing awareness among patients and providers about reporting adverse events, social media connectivity resulting in a huge influx of data, and multiple templates or formats. 
    2. Given the shortage of safety talent compared to demand and the pressure on businesses to cut expenses associated with manual case processing because of the rising number of adverse occurrences, it is urgent to review the old manual methods of case processing. 

    Switching to adaptive case processing is required

    • The need for pharmaceutical companies to deploy and maintain more complex PV systems and manage safety surveillance activities is growing because of the changing regulatory environment and increased regulatory scrutiny, increasing disease complexity and the number of drugs getting approved, and growing awareness among patients and providers about reporting adverse events, social media connectivity resulting in a huge influx of data, and multiple templates or formats. 
    • Due to the lack of safety talent compared to demand and the pressure on businesses to reduce expenses associated with manual case processing because of the rising number of adverse occurrences, it is urgent to review the old manual methods of case processing.

    Case Processing Automation: Methods and Advantages

    • A typical roadmap for implementing an automation strategy would begin with process mapping and assessment to drive process improvements, make end-to-end case processing superior and leaner, and eliminate repetitive steps in existing processes.
    • Artificial intelligence technologies can be used to transform the way pharmacovigilance case processing is done, making it smarter at every stage with less need for human intervention. These technologies range from basic automation through robotic process automation to cognitive automation with natural language processing, and finally taking to machine learning. 
    • Although there are accessible cloud-based technologies, such as Oracle Argus, ARIS-G, etc., that automate case processing and reporting tasks, the process still necessitates a significant amount of manual labor during case intake and data entry. These operations are great candidates for automation utilizing RPA/AI technologies through the detection of patterns in unstructured data since they are rules-based, repeating, and generalized.
    • Automation of the entire process from case receipt to reporting can limit manual intervention to specific activities like handling exceptions, quality assurance, and medical review.
    • With the combined expertise of pharmacovigilance domain experts, data scientists, and IT engineers, standardization and automation strategies for PV processes have the potential to increase case process efficiency, leading to a significant cost reduction. They can also decrease manual errors, improve the quality of the deliverables, and guarantee regulatory compliance due to faster turnaround times. 
    • Through a clear vision, well-defined strategies, and implementation plans with mileposts to monitor progress at each stage and metrics to monitor effectiveness and benefits, the adoption of these novel technologies can therefore add a new level of speed and intelligence to the pharmacovigilance process.
    • Businesses that recognize the value of incorporating these cutting-edge disruptive technologies and utilizing them will fundamentally change the landscape of drug safety, be more effective in managing the increasing case volumes with better quality, and ultimately comply with the regulatory requirements related to the safety surveillance of their products.

    Create a pathway and learn in multiple ways and don’t hold yourself back. Optimize and reap your career right now!

  • Why do Dental Students Prefer Drug Safety as a Career

    Why do Dental Students Prefer Drug Safety as a Career

    In today’s world, a dental graduate has a plethora of career options.

    Contrary to popular belief in other fields, transitioning from clinical dentistry to drug safety or pharmacovigilance can be a lucrative career move.

    The curriculum for a dental graduate is not only comprehensive, but it also serves as a foundation for drug safety. Those with a keen interest in Physiology, Pharmacology, Medicine, Oral Medicine, Diagnostics, and other subjects, need not look any further.  

    Dentists play an important role in society as professional health care providers. When playing the role of a Drug Safety Associate, advanced drug safety training will add to their knowledge.

    Many dentists have co-authored clinical research papers and patient reports while under the supervision of subject matter experts at the undergraduate level.

    As observed in various studies, some of the common factors that motivated dental students include 

    1. Attaining financial security 

    2. Becoming an expert professional 

    3. Job satisfaction 

    4. Service to the common man

    This foundational knowledge lays the groundwork for the vast field of clinical research and trials. The knowledge is useful for triage, case processing, review, and analytics.

    Why do Dental Students Prefer Drug Safety as a Career

    A career in drug safety appears to be the appropriate chess move with the shift in medical and dental treatment perspectives. Understanding students’ intentions can aid higher education providers with a complete and accurate picture of the profession.

    A move in the profession as a Drug Safety Associate or a Pharmacovigilance Scientist for a dental graduate could prove important and winning for both sides. 

    Sollers college provides students with the training they need to bridge the gap between their qualifications and the skills required for a career in the pharmaceutical industry. 

    Sollers college provides courses by emphasizing cutting-edge training and certification methods. Empowering professionals with the current market skills results in a trained professional with job-readiness skills and knowledge.

    Our course curriculum, in the pharmaceutical industry, will guide you on your drug safety career path.

    Sollers college provides Advanced Drug Safety courses to meet a variety of training requirements.  Take advantage of the course formats.

    What about a time-bending approach? Looking for advanced training? To read more on this, you have a choice@ Sollers college.

  • What exactly is pharmacovigilance, and why is it so crucial?

    What exactly is pharmacovigilance, and why is it so crucial?

    Pharmacovigilance strives to increase patient safety by conducting ongoing investigations, and identifying and monitoring previously unknown adverse effects, it is critical to ensure that any medicines developed and manufactured by pharmaceutical companies are effective and do not pose a serious risk to consumers. Pharmacovigilance is the science of collecting, detecting, assessing, monitoring and preventing adverse effects of pharmaceutical products. 

    Pharmacovigilance Eligibility Requirements

    1. Aspirants to pursue a professional career in Pharmacovigilance.
    2. Graduate or postgraduate degree with at least aggregate marks.
    3. Pharmacy or Pharmaceutical Sciences graduate or postgraduate degree.
    4. Medical graduates and a bachelor’s degree in a relevant subject, such as life, health, or pharmaceutical sciences, are required.
    5. When it comes to drug safety, the career path is very straightforward, in both perpetual and procuring capacities.

    Skills required to start a career in Pharmacovigilance

    What exactly is pharmacovigilance, and why is it so crucial?

     

    Pharmacovigilance-Career Prospect

    Young professionals are hired as a junior or an assistant before their functional job titles such as Junior or Assistant Project Manager. After gaining experience, the prefix can be changed to Senior Project Manager.

    Many young scholars begin their careers in the pharmaceutical industry as employees, which then outsource them for a set period to a pharmaceutical company for a specific job. Then after, these young professionals will choose their future career development. 

    Fresh graduates typically begin thinking about their career development in the pharmaceutical sector after a period of varying work experience. Whether you want to remain an expert in your field or become a manager or leader, each requires different skills, training, and work experience.

    No matter what role or level of position, pharmacovigilance professions require excellent communication skills.

    Pharmacovigilance is regarded as an excellent career option for those interested in a well-defined and expanding career path. There is a faster career progression leading to managerial and director roles eventually, as well as a decent salary package. The entry-level job for someone looking to start a career in Pharmacovigilance is that of a Drug Safety Associate. 

    Progression to a more senior role, such as Team Lead or Director, which carries more responsibility and allows to manage teams.

    Pharmacovigilance- Positions

    Drug Safety Associate

    • This is the entry-level position in Pharmacovigilance, and most students pursue it after studying Pharmacovigilance. 
    • Drug safety associates are pharmaceutical, life science, nursing, or medical graduates who specialize in monitoring adverse drug effects in patients and reporting these effects for review and drug modification. 
    • Drug Safety Associates are primarily responsible for case creation, data entry of all information available in the document, reconciliation, checking for minimum safety information, and the follow-up process. They will be required to submit reports to regulatory authorities. 

    Drug Safety Scientist 

    • Another important career option in Pharmacovigilance is drug safety scientist. After gaining years of experience as a DSA, a person can become DSS. 
    • A drug safety scientist should have complete knowledge of medical coding, a good understanding of medical terms, and a general understanding of regulatory affairs.
    • DSS’s job is to ensure that pharmaceutical products are both effective and safe. They oversee detecting and reporting adverse drug effects.

    Aggregate Report Scientist 

    The aggregate report scientist is the next step in the Pharmacovigilance career path. This entails compiling a drug’s safety data over an extended period. This position can be obtained after gaining good narrative writing experiences in individual cases, such as writing PADER.

    • The purpose of a PADER report is to provide any new information obtained from the source medicine.
    • It analyzes data to identify any exposure to the medicine.
    • Compile information on the status of the medicine’s approval in various countries and regions.

    PADER Technical Specifications

    • It’s a single pdf file that includes the table of contents, bookmarks, and hyperlinks.
    • A Study Tagging File (STF) is not required to submit PADER’s descriptive part in eCTD format.
    • The reporting period is included in the PADER/PAER title, whereas the leaf title follows a standard format for future submissions.
    • PADER supports hyperlinking, which will aid reviewers in understanding the document.

    Sollers add value by providing a reference for appropriate fields. Let us work together to create a better future! Learn about Sollers Career Guidance.

    • assistance is given – hands-on database and system training
    • assist in achieving results – gaining extensive experience
    • assistance with references
    • assist in establishing necessary contacts
    •  career advancement features

    Sollers College offers Master’s, Bachelor’s, short-term programs, and certificate programs in Life Sciences. Clinical trial management, advanced clinical research, drug safety, and pharmacovigilance are the main topics of our courses. 

    Sollers unique program always opens a wide range of career opportunities in the pharmaceutical industry and provides the right guidance for professionals with quick support for learning. 

    Sollers offers training programs to students who are ready to build their profiles. 

    Sollers designed a pathway to the vast pharmaceutical industry to learn and demonstrate your expertise. Don’t let yourself be held back in this pharma and drug industry to match your requirements.

  • Pharmacovigilance_ The Next Booming Career Option

    Pharmacovigilance_ The Next Booming Career Option

    The global coronavirus pandemic has resulted in many fatalities, making pharmaceutical safety reporting and monitoring critical in the context of potential therapeutic regimens. Pharma businesses outsource the pharmacovigilance process to reduce fixed overhead costs and large upfront investments, gain additional capacity, and boost resource flexibility. 

    For small and medium-sized businesses, outsourcing pharmacovigilance is a cost-effective option. The greater awareness of pharmacovigilance’s significance, the investigation and marketing of a broader range of pharmaceutical products, and more strict and detailed regulatory criteria have all contributed to this growth. The pharmacovigilance and drug safety market are growing as a result of such advances among pharma firms.

    The primary purpose of pharmacovigilance is to enable the use of drugs in a safer way. However, it is under increasing pressure to analyze more data more quickly, monitor hazards more extensively, and accurately report worldwide patient events. 

    What is Pharmacovigilance?

    Pharmacovigilance (PV) entails tasks such as monitoring, detecting, and preventing adverse effects or other drug-related issues. 

    It is a continual process that includes actions to improve the safe use of medicines while also evaluating their safety. Pharmaceutical businesses are thought to have the biggest market share in the pharmacovigilance end-user segment.

    Pharmacovigilance (PV) data is crucial in identifying viable treatment options for COVID-19 and finding a means to minimize or reduce morbidity and mortality. The influx of clinical and PV data includes new therapeutic information for COVID-19 treatment as well as possible drug interactions to consider.

    Pharmacovigilance databases can be utilized for a wide range of observational research and contain numerous real examples, making them a valuable source of data. It primarily focuses on reporting and assessing pharmacological adverse effects, as well as assuring that drugs are safe and secure.

    The use of correct analytics is critical, yet firms often prioritize data processing over analysis, resulting in sub-optimal results. Integrating intelligent technologies all the way through the value chain can be beneficial. 

    Are you eager to expand your professional horizons?

    Don’t worry, we’re here at Sollers to assist you and satisfy your preferences with scientific understanding. At Sollers, you can learn, train, and take courses to expand your expertise. Without a doubt, learning new skills and learning about drug safety and pharmacovigilance is a simple process.

    So, what are you awaiting?

    Join Sollers to gain professional pharmacovigilance and drug safety training and expand your knowledge. You can rely on us for in-depth training in this competitive area, whether you are a recent college graduate or a working professional. 

    Use our global experience and tried-and-true technology to keep yourself safe from the start. Companies will concentrate on simplifying and reducing costs in the next years.

    Throughout the compliance paradigm, our comprehensive methodology delivers the next generation with focused value-creation areas you’ve never seen before.

    To sum up, pharmacovigilance innovation is never-ending. With new advances in pharmacovigilance, there will be numerous advanced technology solutions in the future.

  • Drug Safety & Pharmacovigilance prominence in the coming years

    Drug Safety & Pharmacovigilance prominence in the coming years

    Drug Safety & Pharmacovigilance prominence in the coming years

    It is impossible to overstate the importance of Pharmacovigilance, but do you know what it entails? Sollers college can help you shape your career in drug safety & pharmacovigilance by explaining what it is, why it matters, and how it works.

    Let’s have a look at it. 

    In pharmaceutical production, Pharmacovigilance is the beating heart, and it is not possible to assess the effectiveness of drugs and about their side effects without it. Known as PV, Pharmacovigilance is intended to protect patients and enable professionals to share knowledge to minimize adverse events. 

    Monitoring safety after approval is crucial. Assessing the actual risk-benefit profile of the medicine during its entire life cycle and taking the necessary precautions to minimize the risks enables effective long-term monitoring to ensure the safety of drugs.

    In addition to analyzing individual case safety reports and aggregate reports, risk management involves mining pharmacovigilance safety databases, detecting signals, and implementing risk management programs.

    Trends expected to be seen this year and how they will impact life sciences careers:

    – High Industry growth

    Due to the pandemic’s surge in demand for talent, there is fiercer competition than ever before. A skills gap between supply and demand poses challenges for employers. Candidates with experience in the healthcare, biotech, and pharmaceutical industries will be in high order. Life sciences companies would have a longer recruitment process to fill jobs, especially in niche fields.

    Every year, life sciences companies face new challenges and opportunities, but 2022 will be the year when it is in the spotlight more than ever. As per the US Bureau of Labor Statistics, occupations across life, physical and social sciences are expected to grow seven percent by 2028. It is expected to be faster than the average for all other occupations. There will be about 97400 new jobs within the next decade.

    – Demand for Technological expertise is on the increase

    As technology and life sciences converge, the need for professionals with the skills to deliver technology-enabled solutions has grown. Companies will remain at the forefront of a rapidly evolving industry in 2022 and beyond with biotech, data analysis, and digital product management roles.

    With the rapid advancements and inventions in pharma worldwide, unpredictable harm is possible. 

    Toxicology and adverse effects of medicines must be continuously monitored worldwide. It is important to report, analyze, and act on such issues. Due to the high demand for improvised drugs, many unauthorized companies enter the market without following the specified standards. Improperly manufactured drugs can have adverse health effects. Medicine quality must be continuously monitored. Thus, Pharmacovigilance plays a vital role in meeting the challenges of regulating & monitoring drug safety.

    To ensure global health, Pharmacovigilance must ensure that risks are anticipated and managed, regulations are implemented correctly, and communication between health professionals and the public is improved.  

    With the increasing drug consumption, the need for regular monitoring of drugs has also improved, gradually boosting Drug Safety and Pharmacovigilance demands. Sollers College is providing various certificate programs in Advanced Drug Safety and Pharmacovigilance to make a significant impact in the life sciences sector. 

    Contact the admissions team at admissions@sollers.college or call at 848-227-4151 to know more about the programs.

  • Pharmacovigilance Trends in 2022

    Pharmacovigilance Trends in 2022

    In recent years, the demand for pharmacovigilance surged due to increased medicine consumption and a rise in disorders and diseases. A growing number of adverse drug reactions (ADRs) is leading to the need for new and effective pharmacovigilance solutions to curb this trend. There is an increasing challenge of keeping up with recent advancements as the industry changes. 

    Medicines can have unintended adverse effects that only become apparent after being on the market for a prolonged period. It is critical for pharmaceutical firms and regulators to keep track of and report adverse occurrences.

    It is anticipated that the pharmacovigilance market size will increase at a CAGR of 10.5% between 2022 and 2030, reaching USD 17.36 billion.

    For pharmacovigilance service providers, Covid has presented both obstacles and opportunities. Due to the limited availability of clinical resources and research workers during Coronavirus lockdowns, the number of active clinical trials decreased. Patients were restricted, which resulted in new work standards, frequent audits, and safety inspections. 

    Furthermore, the healthcare sector’s growth in the usage of medications (whether licensed for Covid or used off-label) has prompted them to work around the clock to ensure that goods are safe. 

    The pharmacovigilance sector is progressively adjusting to new trends ascribed to improved and more effective data gathering and analysis to capitalize on such growth prospects. 

    Resource Scaling

    There was a substantial increase in Adverse Effects during the epidemic (AEs). The pharmaceutical sector has to grow its in-house resources and increase its staff to manage this task efficiently. 

    There has also been a rise in the number of outsourced manual jobs, such as data collecting and input. With the addition of key performance indicators (KPIs) and specialized teams, the scaling process has been improved, resulting in more flexibility.

    Pharmacovigilance automation

    Automation can benefit many aspects of pharmacovigilance. As our clients have verified, automating pharmacovigilance has several advantages: it eliminates human error, decreases expenses, and saves time. This aids in the management of vast volumes of data as well as ensuring compliance.

    By adding any written material on the topic, such as product and illness descriptions, patents, case reports, clinical studies, and so on, our Iris.ai tools can automatically discover the documents you require. You may summarise and extract all pertinent information from them. By freeing up this time, PV experts will focus on other value-added duties.

    Pharmacovigilance requires basic automation to guarantee automated tracking, job monitoring, and data gathering. Automation can transform the way data is collected and evaluated, thereby speeding up clinical studies. 

    Electronic data capture (EDC), a database used to hold patient data during clinical trials, is known as electronic data capture (EDC). 

    During clinical trials and market observations, EDC-based technologies for data gathering and analysis are efficient. 

    Cloud technology is great for providing all stakeholders with a wholly integrated database, which is critical for increasing medication safety and pharmacovigilance. Robotic Process Automation (RPA) automates data entry, processing, and analysis, removing the need for manual labor. Decision-making can be aided by combining RPA with cognitive automation via natural language processing. 

    Data analysts and data scientists can use artificial intelligence and machine learning to generate predictions based on data analysis. It has the potential to enhance pharmacovigilance processes. 

    Sollers offers a certificate program in Drug Safety and Pharmacovigilance to improve your skills as per the current trend. Enroll now!

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