Sollers College

Tag: Drug Safety and Pharmacovigilance

  • Challenges and Opportunities in Hiring in the Life Sciences

    Challenges and Opportunities in Hiring in the Life Sciences

    Life sciences organizations confront new difficulties in Clinical Trials, Drug Safety etc., and possibilities every year, but 2021 will be the year when they are front and center more than ever. According to the US Bureau of Labor Statistics, professions in the life, physical, and social sciences will expand by 7% by 2028. It will be quicker than the national average for all other vocations. Within the following decade, this would imply the creation of around 97400 new employment.

    The COVID-19 epidemic has also shifted the job landscape by emphasizing the importance of the biological sciences industry.

    Industry expansion is vital. Because of the pandemic’s need, there is a fierce and considerably more demand for talent than ever before. Employers have faced issues as a result of a rising supply and demand mismatch for trained individuals. Candidates with experience in areas such as healthcare, biotechnology, and pharmaceuticals will be in great demand. Companies would have to undergo a more extended recruitment procedure to fill life sciences, especially in specialist areas.

    The need for technological skills is growing. With the convergence of technology and life sciences, there has been a greater emphasis on recruiting personnel with the skills to offer tech-enabled solutions. Biotech, data analysis, and digital product management will be in high demand in 2021 and beyond. Companies will remain ahead of the curve in a continuously changing industry.

    Remote positions are becoming more prevalent. The pandemic has caused a shift in the rise of small labor in a variety of industries. Many conventional jobs in the life sciences industry have gone online and will continue to be distant in the future. The need for remote positions for healthcare practitioners such as physicians, nurses, and other clinicians has increased as telehealth services have been more widely adopted.

    Biopharma and life sciences businesses are now competing with technology companies for specialized sector personnel, such as computational biologists and bioinformaticians, in addition to seeking the same talent pool as other industrial sectors for general digital skills. 

    Are you prepared to take chances on applicants with less experience but a desire for innovation?

    That is very dependent on the function. In some instances, especially in specialized areas, you cannot afford to take the risk or devote the time to train individuals up. In other cases, hiring for potential and enthusiasm makes excellent sense. 

    Sollers provides certificate programs in various life science fields such as Clinical Research, Clinical Data Science and Drug Safety & Pharmacovigilance. 

  • Future prospects of Pharmacovigilance

    Future prospects of Pharmacovigilance

    Why is Pharmacovigilance required in pharmaceutical markets for all countries? Majorly it is due to adverse drug reactions (ADR) that leads to severe illness, permanent side effects, and even death.

    With rising burden of chronic and non chronic diseases and increase in geriatic population growing pharmaceutical market, no surprise that there is a rapid growth for pharmacovigilance services  in worldwide market. Pharmacovigilance performs a much more pivotal role with the more stringent regulations and the increasing quality of patient centricity than 10 or 20 years ago.

    Current industry trends in pharmacovigilance:

    These days, the evolution of mobile applications, digital health devices, social media set a new standard for patient involvement. Recent statistics illustrate that there is a huge value for social media monitoring and provide valuable information related to drugs. Along with that proactive monitoring helps to give early warnings of new adverse events that helps in drug development and avoid preventable litigation.

    Will the exponential growth of digital health tools become primary for producing high-quality concerns? It stands to reason that proactively observing patient health through digital health materials could provide insight into decreasing the figure and severity of adverse events.

    Social media; Clinical data and electronic health records; Claims files;

    Regulatory reports and filings from different areas;

    ​Secondary data references present unprecedented difficulties in terms of procurement and combination with “classic” data sets. Usage of secondary data by pharmaceuticals is, as of today, just at the initial stage, also considering that it is not required from the regulatory point of view. 

    Recently, technology providers have started giving robust and flexible platforms that support Life Sciences organizations handling and combining multiple file types and including social media streams in their pharmacovigilance methods. Advanced algorithms and disproportionality review are now being developed to accommodate classical automatic reporting and social media streams.

    The secondary data references and advanced signal detection technologies help detect safety risks and take more rapid risk minimization.

    Cloud-based Reporting produces a robust global database of adverse events.

    Many businesses are now profiting from collecting and analyzing vast amounts of data in the cloud. As the amount of data sources grows, Life Sciences companies confront the critical need to optimize the intake, storage, and study of substantial volumes of data.

    The primary reason for transforming to the Cloud is

    Cost and efficiency: Cloud enables organizations to operate with massive data from incidents without yielding security, quality, and data privacy.

    Scalability: The adverse event case workload for Life Science companies has been growing regularly, with some businesses seeing a 50% rise yearly. 

    Simplicity: Cloud usage can simplify the life of companies by empowering them to evade concerns about module adaptability and mounting up servers. Cloud pharmacovigilance is a growing reality. 

    Sollers college provides a Drug Safety & Pharmacovigilance certificate/master’s program for the students/drug safety professionals who want to settle in the healthcare sector.

  • What is the Aim of Drug Safety & Pharmacovigilance?

    What is the Aim of Drug Safety & Pharmacovigilance?

    Pharmacovigilance is the heartbeat of pharmaceutical production. Do you think there’s something more significant than the safety of a patient? As a healthcare provider, your patient safety is your preference. Drug Safety & Pharmacovigilance, is intended to protect patients and disseminate information amongst professionals to reduce the risk of adverse events. You perform a risk-benefit estimate for every patient before any interruption or treatment decision is focal to keep your patient safe. Therefore, any science or activity that reinforces this concept is of great importance. And here, we can discuss the significance of pharmacovigilance.  

    What is Pharmacovigilance?

    The pharmacovigilance field is broad-ranging. It comprises drug interactions, prescription errors, lack of drug efficacy, unapproved medications, fallacious use of medicines, severe and persistent poisoning, case reports, drug-related mortality, and anything related to adverse drug reactions. 

    To succeed in this event, pharmacovigilance aims to regulate the adverse drug effects through its central international database, which accumulates the adverse effects of drug reports from all the countries worldwide. And now, let us have a broad discussion on the significance and consequence of pharmacovigilance.

    The importance of Pharmacovigilance:

    We have shown a notable rise in the number of clinical trials through the past few years, and this happening is a double-edged weapon!

    Although new medicine development is essential for a large portion of patients, the number of clinical trials may affect the function of ethics committees and regulators, which may lead to unethical patient practices, poor reporting of adverse effects, and inadequate patient monitoring during the phases of clinical trials. 

    What does pharmacovigilance do?

    The role of pharmacovigilance is to assess whether the benefits of a drug outweigh the risks, and it doesn’t stop after the medicines are certified. PV involves ongoing monitoring of medications to ensure they remain safe for use, primarily since previously undetected adverse events can occur at any time.

    This position has a significant impact on improving the medicines’ safety profile, intensifying patient care and safety, and also supporting the work of national drug regulatory authorities.

    The Quality of Pharmacovigilance in Clinical Trial Regulation:

    With the transformation on trends in clinical trials and altering demographics of the patients taking the medicines, outsourcing pharmacovigilance has been indulged as they have the proficiency to centralize data and hence, early identification of risks; guaranteeing the final aim, that is, the safety of human health is completed.

    The significance and roles of pharmacovigilance are vital; they are growing and extending throughout the years to incorporate various methods related to patient safety. Upskill your career with Drug Safety & Pharmacovigilance certification from Sollers.

  • Role of Pharmacist in Pharmacovigilance Field

    Role of Pharmacist in Pharmacovigilance Field

    The Pharmacy profession has experienced significant change over the last two to three decades. Pharmacists can use Pharmacovigilance systems interfaced with electronic health records to observe the drugs they fill and recognize adverse drug reactions quicker than non-pharmacists, thereby decreasing expensive healthcare costs.

    Pharmacovigilance information systems managed by pharmacists can recognize adverse drug reactions in emerging countries where quality control of medicines is questionable. Reports suggested that patients had insufficient knowledge about their prescribed drugs, although they had been using them for a while. 

    73% of pharmacists work in hospital or pharmacy settings, where they can face events based on adverse drug reactions or other drug-related problems. Their involvement in pharmacovigilance systems is crucial.

    The development of electronic information systems has been a milestone in identifying and intervening drug-related problems such as dosage, adverse reactions, interactions, compliance, or ineffectiveness. Such decision support systems in electronic medical records can capture drug-drug interactions or identify other issues (e.g., contraindications) with prescriptions before they are filled

    Pharmacists have a crucial role in the US and health systems to maintain the rational and safe use of medication, for they are drug experts who are specifically trained in this field. They ensure that the drugs in the marketplace we consume are generally safe, and all those identified as hazardous are taken off the market. 

    Pharmacovigilance is an excellent employment option for medical, pharmacy, and life science graduates. It has resulted in pharmacists taking on greater responsibility in managing minor illnesses and delivering public health interventions. There is no limit to the patients dealt with by pharmacists. 

    In the pharmaceutical sector, the number of career opportunities is nearly limitless. Pharmacists can play a role helping patients with chronic diseases have better medication at the correct time and get good clinical outcomes. Pharmacists serve as patient advocates, contributing information that permits patients to evaluate risk and improve their autonomy

    The pharmaceutical industry in the US is one of the most advanced industries of the country and the third-largest in the world. It is technologically strong and self-reliant. Effective use of pharmacists’ workforce will improve the outcome of pharmacotherapy and decrease global health costs. 

    Pharmacists can fully use their clinical abilities and usually involve diagnosis and therapeutic management. More than ever before, community pharmacists are now in a position to identify, record, and report medication safety incidents. 

    Sollers’ Drug Safety and Pharmacovigilance certification help Pharmacists to enrich their career growth in the Pharmaceutical sector. It might seem like a lateral move at first, but it will open more fantastic opportunities in the long term. 

  • Scope of Pharmacovigilance in Coming Years after COVID Vaccine

    Scope of Pharmacovigilance in Coming Years after COVID Vaccine

    2020 gave rise to the most devastating epidemic in modern history, but it also provoked amazing breakthroughs across Clinical research and Pharmacovigilance stewardship. Rising incidences of ADR during COVID vaccine have elevated the importance of Pharmacovigilance in the market.   

    As per the reports, from 2020-2027, the market is estimated to grow with a 7.6% CAGR, and the global market is expected to grow nearly triple to $12 billion by 2027 with the surge in the application for electronic health record mining, intensified drug report monitoring, cohort event monitoring, spontaneous reporting.

    There has been a steeping demand for pharmacovigilance services because of the developing predominance of chronic diseases, respiratory disorders, cancer symptoms, and rising drug consumption.In addition to this, a vast rate of adverse drug reactions (ADRs) have added a substantial strain on the healthcare sector, pointing to the augmented demand for Pharmacovigilance.

    The increasing trend of outsourcing PV services to CROs and BPOs has derived from an effective drug regulation system. These outsourcing substances contribute to pharmacovigilance services with high regulatory compliance, improved productivity, and more remarkable strategic outcomes, thus expanding the global PV market. 

    The critical factor for expanding the pharmacovigilance market is the governments’ strict drug safety policies and regulations.  Also, around 5% of total hospitalizations are due to those adverse reactions. Therefore, the scope of pharmacovigilance is cumbersome as countries have to produce solutions to evade these adverse drug reactions.

    Intense post-market monitoring mechanisms set up by various government regulatory agencies increasingly focus on the safety and efficacy of pharmaceutical products after they are launched in the market.. So, there will be no shortage of jobs in this sector. Candidates will obtain many job openings in pharmaceutical companies along with a few positions in the public sector.

    To make a more glorious future in Pharmacovigilance, enroll in Pharmacovigilance Courses to get the best training from industry experts. Sollers offers certification and a Master’s program in Drug Safety and Pharmacovigilance along with Adverse Drug Reaction programs. 

  • Evaluation of Adverse Drug Reactions

    Evaluation of Adverse Drug Reactions

    Pharmacovigilance is an arm for patient safety and care that aims to get the best results with medicines’ treatment. Unfortunately, because of many different factors, any medicine can  sometimes cause adverse reactions. 

    As we can see, the world of 2021 is different compared to previous years. We are now cautiously reopening and trying to get into the new normal state. Pharmacovigilance will recognize the risks in the least possible time when the medicine has been marketed and will aid to build and/or classify risk factors. When communicated adequately, this data enables intelligent, evidence-based guiding with potential for stopping many adverse reactions and will finally benefit each patient to obtain optimum therapy at a more economical cost to the health system.

    Adverse outcomes, preventable or otherwise affects the treatment. Mainly adverse events affect patients, but they also affect health care practitioners. Revealing information about adverse events has benefits for the patient and the physician and, ideally, strengthens the patient–physician relationship and promotes trust. 

    When to report

    A patient should communicate if they had a notable outcome.They can go to hospital and inform the medical advisers that they stopped using medication as they have this type of adverse reaction 

    FDA encourages the consumers to report whenever they find any adverse reactions. If the team gets bundles of reports about the same medicine they will respond and take possible actions. 

    What happens after a report is made?

    FDA examines all submitted reports and identifies the similar adverse events occurring with a specific medicine. 

    Depending on the severity of the adverse reactions, FDA may take any of the following decisions. 

    • Withdraw the medicine from the market 
    • Declare a drug safety communication to notify public 
    • Set some restrictions on the drug distribution
    • Renovate the drug’s labelling, insert or package.

    But almost everything starts with consumer feedback. Adverse event reporting allows us to do our job and report needed information back to consumers.

    Types of Adverse Drug Reactions:

    Mainly it is classified under

    • Dose-related
    • Allergic
    • Idiosyncratic

    In detailed it is segregated as 

    Type A – Augmented 

    Reactions which can be predicted from the known pharmacology of the drug. These are dose dependent.

    Ex: Bleeding, Headache etc., 

    Type B – Bizarre

    These are adverse reactions that depend upon promoting the growth of certain microorganisms and cannot be predicted from pharmacology.  

    Ex: Anaphylaxis, Hypersensitivity

    Type C – Chemical 

    Several adverse reactions rely upon the chemical nature of a drug rather than pharmacological properties and cause chemical irritation.

    Ex: Hepatotoxicity

    Type D – Delayed

    These reactions occur because of the physical nature of the formulation or the method of administration.

    E.g. Chemotherapy,   Secondary tumours,  Teratogenic effects

    Type E – Exit/End of treatment

    These are known as withdrawal reactions, these occur on withdrawal especially when drugs are stopped abruptly. 

    E.g. Phenytoin withdrawal  Seizures, Steroid withdrawal

     Type F – Familial

    Familial dysautonomia is a hereditary sensory disorder. It is a genetic disorder that affects the development and survival of certain nerve cells.

    Ex: poor muscle tone (hypotonia), frequent lung infections, and difficulty maintaining body temperature. 

    Type G – Genotoxicity 

    Several drugs can create genetic damage in humans. Distinctly, some are possibly genotoxic or carcinogenic. Few, but not all, teratogenic agents harm genetic material within the fetus.

    Type H -Hypersensitivity

    These are side-effects induced by hypersensitivity or allergy. They are apparently the most frequent adverse reactions after Type A reactions.

    Type U – Unclassified

    Some adverse reactions have a mechanism that is not known. This may constrain the introduction of new adverse reaction divisions in the future. Examples include muscular adverse effects,drug-induced taste disturbance.

    Drug Safety and Pharmacovigilance Training Program accomplish the demands of this ever-growing and profoundly regulated industry by offering a curriculum aligned with the real-time industry requirements, highly competent, and equips career readiness for professionals in the pharmaceutical industry.

  • Evolvement of Pharmacovigilance in Coming Years

    Evolvement of Pharmacovigilance in Coming Years

    Pharmacovigilance (PV), the method of identifying, tracking, evaluating, and anticipating adverse outcomes from drug therapies, is a division that has seen enormous growth in recent years. Hence Pharmacovigilance training becomes necessary to meet the current requirements.

    The pharma industry is welcoming the huge transformation initiatives at a faster pace than ever over the coming years. The difficulties of building and maintaining progressively more complex pharmacovigilance systems in a globally different and evolving managerial environment are growing day by day. 

    Leveraging technologies – including mobile applications, cloud-based solutions, and technology for big data analytics – will allow companies to move toward end-to-end automation across the PV spectrum. Embracing advanced technology solutions and next-generation automation will position companies to meet the future’s PV challenges and stay ahead of the curve.

    Strong technical and PV experience is expected to drive the highly regulated policies while giving comprehensive, end-to-end PV automation solutions. Pharmaceutical companies started defining a clear vision, building strategies and initiatives with specified milestones and selecting strong Drug Safety professionals with a proven track record in PV delivery, safety technology, and regulatory reporting.

    Close the information gap and lead pharmacovigilance from a state of reactive to proactive? It demands some proactive planning and partnering to spool-up a patient adherence and patient support program, but you can be ready with the right partner.

    The new tools, data, and procedures are unquestionably paving the way to a more radiant and insightful prospects.

    •  The requirement for making pharmacovigilance following to its primary focus.
    • The demand for a whole systems approach.
    • Having a united drug safety-clinical database for advanced data acquisition.
    • Necessitate for regulatory harmonisation.

    Automation and standardization of PV processes and safety data management boost efficiencies, quality and compliance. Proactive PV knows and predicts rising safety signals in data mining techniques. Superior cognitive solutions extract, code and process AE data while AI empowers clear views of safety issues, giving transparency to establish trust.The main objective of Pharmacovigilance is that detecting the drug-induced adverse reactions in medicine’s life cycle to take appropriate actions to minimize the impact on patients.

    Are you looking to do job oriented certification in drug safety pharmacovigilance? Get an edge to your skills with these popular tech skills. We leverage our decades-long expertise and experience to maximize your opportunities in coming years.

  • Role of PV & Clinical Trials in Covid-19 Vaccine

    Role of PV & Clinical Trials in Covid-19 Vaccine

    COVID-19 pandemic has generated various challenges and opportunities across the healthcare landscape. The pandemic is shining a flashlight on how these technologies can support organizations quickly and correctly to drive complex administrative provisions, especially in the face of a massive influx of new data treatments for COVID, which are taking place worldwide with the help of Clinical Trials and Pharmacovigilance. 

    The volume and speed of clinical research to discover effective drugs against novel coronavirus has been exceptional. The regulations are made adjustable and convenient without any relaxation in drug safety reporting to address the unmet medical requirements. 

    The pharmacovigilance actions, primarily adverse event reporting despite clinical practice and clinical trials, should continue because patient safety is superior. PV system analyses collect and share drug safety data while aiming to reduce risk to patients in the shortest possible time. PV will apply to both approved drugs and under clinical trials. 

    Biopharmaceutical organizations and health experts are purposefully driving faster and more flexibly than they ever have before. While there is colossal urgency to scale and create these medications quickly, this cannot damage safety and efficacy.

    Owing to the need to produce vaccines quickly during the COVID-19 vaccine research and production, the pharma companies and scientists overcame pharmacovigilance challenges in four major ways without compromising the quality of creating vaccines.

    • Mass Data Collection
    • Regulatory & Safety Reporting
    • Patient Services
    • Mass Manufacturing & Distribution

    Providing the industry with real-time pharmacovigilance data enhances the ability to foretell and respond to safety interests as they happen, not only heightening regulatory compliance but also improving patient safety in both the short- and longer-term. 

    In the longer term, aiding in the business of proactive safety practices will give pharmaceutical companies the competing edge they require to see gaps and possibilities in the life sciences landscape and drive medicine innovation for the world at large.

    With Sollers‘ help, anyone can exceed all the essential tools and technologies. Power your career with Clinical Trial Management and Drug Safety and Pharmacovigilance certification. Sollers College aims to help those who want to begin their career in the healthcare sector; healthcare professionals also accomplish mid-level positions with the certification program’s help.  

  • Importance of Aggregate reporting in Pharmacovigilance

    Pharmacovigilance is the science which deals with the activities related to the detection, assessment, understanding, and prevention of ADRs. The scope of Pharmacovigilance has evolved. We now recognize the significance of a systematic approach to monitoring and improving the safe use of medicines. Aggregate reporting is the process that examines the collective safety information from a broad range of sources systematically and gives the conclusions to regulators worldwide. 

    The aggregate safety records are presented to regulators as soon as the medicine is marketed all-around and facilitates understanding of the product’s risk and benefit profile over time. These reports focus not on individual cases, but preferably on overview, assessment of the safety profile and benefit-risk-evaluation of Adverse Drug Reaction (ADR) and the Serious Adverse Event (SAE) and pregnancy reports. 

    Why is aggregate reporting critical in Pharmacovigilance?

    Though the Original case safety reports were tendered on an expedited basis to regulatory authorities, detailed analysis and evaluation of a drug’s benefit/risk ratio are not possible at this level. Therefore, periodically reviewing safety reports received cumulatively worldwide becomes highly significant to analyze the product’s benefit/risk balance. These reports need exceptional diligence and attention to detail, including an overview and a sense of what is essential, on the other hand.

    At the individual case safety reports level, marketing authorization holders (MAH) can’t evaluate the benefit/risk ratio profile and understand a medicinal product’s detailed safety feature.  In addition to presenting individual case safety reports, MAH also evaluates regular reviews of collective safety information obtained from various sources and presents the conclusions of aggregate reports to drug regulators. 

    Types of aggregate reports:

    Pre-marketing report:

    • Clinical study reports (CSR)
    • Development Safety Update Report (DSUR)

    Post-marketing report: 

    • Periodic Safety Update Report (PSUR)/Periodic Benefit-Risk Evaluation Report (PBRER)
    • Periodic Adverse Drug Experience Report (PADER). 
    • NDA and ANDA annual reports

    Aggregate reporting is an indispensable tool to analyze a medicinal product’s benefit/risk balance throughout its life cycle. 

    Take the subsequent step toward your professional aims with Sollers. Learn in-demand skills in life sciences and build and practice skills that will set your resume apart.

  • The Role of Pharmacovigilance in Clinical Trials

    The Role of Pharmacovigilance in Clinical Trials

    Clinical trials are used everywhere to discover a chemical or biological compound’s safety and efficacy concerning its actions on marks or a known disease process. Pharmacovigilance drives with clinical trials that provide data on the risks and advantages of the drug. Pharmacovigilance in clinical research tries to discover whether the benefits exceed the risks; if they do, drug manufacturers take steps to obtain approval to market the new drug.

    Trials are strictly monitored by an investigator and the pharmaceutical company involved in developing a medicinal product. However, the process also benefits from an independent review by drug safety firms. Pharmacovigilance matches this process; to provide an extra security level to assure those safe & effective products touch patients. As part of the global healthcare, drug developers, manufacturers, pharmaceutical systems, and investigators are responsible for implementing the best possible care for the patients and consumers worldwide.

    Phase I, II, and III clinical trials are needed before a drug company can apply for a new medicine’s market authorization. They are responsible for the research’s conduct and then feed it back to the sponsor (the pharma company). During clinical trials, the analyst gathers and analyzes serious adverse events (SAEs), finding whether the drug in question caused the SAEs. If they conclude that the adverse side effects were causal, they are categorized as adverse drug reactions (ADRs).

    The analyst gives this data to the pharmaceutical company responsible for the drug’s R&D (research and development). It is imposed by the pharmaceutical company’s in-house PV team, and the patient files undergo medical review. The PV team fixes if the drug is effective and safe to advance to the next stage of clinical research or to submit an application to the regulatory authority for approval to go to market.

    If approved, the drug company may conduct Phase IV clinical trials to produce additional data on the efficiency and safety profile. These studies help provide data in a less controlled environment, representing how patients are using the drug.

    What is the pharmacovigilance role in clinical research?

    PV in clinical trials is necessary for healthcare professionals and consumers to update the potential risks of medications. The drug company may facilitate postmarketing drug safety surveillance to observe the product’s safety and effectiveness in the real world as it is not possible to predict all possible adverse effects of a drug based on pre-approval studies. Numerous approaches can be adopted, such as; drug registries, spontaneous reporting systems, electronic health records.

    Why is pharmacovigilance important?

    PV analysis conducted in Phase I, Phase II, and Phase III clinical trials gives drug companies data on the drug’s safety profile. This data can be used for extra R&D if required or can be proposed to regulatory authorities to admit new markets to be obtained. 

    PV practices in clinical research give valuable insights into pharmaceutical medications’ safety profile. When a distinct adverse reaction is recognized, the list of side effects on the label must be updated. At times, PV data can remove a drug from the market (drug recall) due to dangerous side effects.

     

     The risk-benefit ratio is improved, monitored, and updated accordingly. After completing Phase III clinical trials and marketing authorization, the pharmaceutical company may conduct phase IV trials to monitor the drug on a much larger scale and in a less controlled real-world environment.

    It is a notable factor that effective, relevant training plays an essential role in overall career development. In very specialized industries such as clinical research, acquiring the right knowledge is immensely important. Earning a degree/diploma from an online institute can probably result in a promotion and salary raise or ready you for a new profession. Sollers helps to ace in Clinical Research, Pharmacovigilance and other life science programs.

     

  • Types of Pharmacovigilance Softwares

    Types of Pharmacovigilance Softwares

    In the age of rapid shift in data and analytics, the pharmacovigilance software paradigm allows the science of pharmacovigilance to advance at a fast pace.

    Pharmacovigilance software database offers alerts for fast cases, follow-up cases, and reports submission to fulfill regulatory timeline compliance. Any pharmacovigilance safety database must be deposited up to date with the most advanced regulatory requirements and certified to meet international standards and business requirements. Safety databases expedite the reporting of individual and aggregate safety data to authorities and third parties and provide critical information for detecting safety signals and the ongoing evaluation of the risk-benefit profile of the company’s products.

    Factors to consider include:

    • Costs of maintenance and Implementation 
    • Hosting models accessibility  
    • Previous experience 
    • Interoperability and Compatibility

    Let’s know the features of the software. 

     

    Name of the Software Distinctive Features

    Oracle Argus Safety
    • Oracle Argus Safety is a vast platform invented to address the complex pharmacovigilance requirements of the life science industry. 
    • Argus Safety’s advanced database helps ensure global regulatory compliance, enables sound safety decisions, and integrates safety and risk management functions.  
    • Origination of cases via case entry screens
    • Tracking of local data items
    • Support for e-signatures
    • Duplicate search capabilities
    • Local labeling decisions made against local datasheet or license
    • Case views provided to appropriate local affiliate
    • Pictures of core documents and global protocols such as action items on a worklist.
    • Central staging area for evaluating submitted affiliate cases
    • Electronic submission abilities
    • Reporting and Querying cases taken and submitted
    • Audit Trails

    ARISg
    • ARISg is also one of the most employed software in Pharmacovigilance used by pharmaceutical firms.. 
    • It is used to manage crucial drug safety data worldwide. 
    • It provides all the functionality needed to manage adverse reaction requirements and adverse event reporting of several regulatory authorizations worldwide. 
    • It allows for all pharmacovigilance methods from case entry to automatic generation of resignation ready adverse event (AE) reports etc., 
    • ARISg forms a core element of an integrated pharmacovigilance and risk management system, allowing organizations to identify safety risks and monitor their products. 
    • ARISg helps advance the management of Adverse Drug reactions using its advanced automation and configurable workflow features.       

    AB Cube: SafetyEasy
    • AB Cube Safety Easy is a compliant-ready multi vigilance database. 
    • Its fully united platform of tools and functionality offers comprehensive and versatile safety data management via a straightforward, intuitive, and user-friendly interface. 
    • SafetyEasy comes with an inbuilt query and reporting functionality.
    • It provides validated outputs designed for expedited and signal detection, case management, periodic reports. 
    • The system is presented as a cloud-based software-as-a-service (SaaS) solution, regularly updated to meet current regulatory standards and     industry specifications.
    • Defining features for AB Cube SafetyEasy are it’s easy to use integrated functionality, user interface, and ease of data movement both into and out of the database.
        Clinevo Safety 
    • Clinevo Safety is currently used by 100+ end clients and is being used to process 100k cases per year. 
    • It is an all-in-one system that provides PV Intake, Case Processing, AI, Analytics, Submissions / inbuilt AS2 Gateway, Signal Management and Safety Analytics capabilities under one platform.
    • Clinevo Pharmacovigilance database / Drug Safety Database includes  Case processing, , PV Intake,Submissions, AI & Analytics, and Safety signals
    • It is database is built on a simplified technology stack which provides a lot of configurations and less customizations
    • It  is the best drug safety database /Pharmacovigilance database which provides end user alerts for cases nearing due dates
    • It consists of easily configurable dynamic workflows for expedited case processing
    • It  provides powerful and actionable insights
    • It is a user-friendly web application which can be accessed with basic internet / intranet using IE, Chrome and Firefox browsers
    • It  complies with all current and emerging regulations including 21 CFR Part 11, ANNEX 11, GxP, and GDPR.
    • It  provides transparent optimized pricing with no compromise in functionality,
    • It provides High performance and efficiency.
    • It  is built on a secured regulatory complaint infrastructure.
    • It works towards reduction of end user efforts through constant automation and AI capability enhancements.

     

    While we have discussed many Softwares in Pharmacovigilance, Oracle Argus Safety is a preferred method for managing drug safety data management. Thus the knowledge of Oracle Argus Safety is quite advantageous to stay connected in the industry today.

    For profound insights into the world of Pharmacovigilance, visit our Sollers website.

    Want to explore a career in Drug Safety and Pharmacovigilance? Join our certification or master’s program in the Pharmacovigilance program and kick-start your career in Pharmacovigilance and get experience working in the Argus Safety database.

  • Exciting Jobs in Drug Safety

    Exciting Jobs in Drug Safety

    Drug Safety has expanded considerably as a discipline over the past few years. Because of its massive prevalence in the market most of the students choose their careers in this swiftly emerging & challenging sector. 

    Today, many healthcare companies are inclined towards Drug Safety. Based on the level of exposure achieved, career progression in Drug Safety can lean towards line management or a more technical direction. 

    Let’s have a look at the trending positions in Drug Safety sector(Line Management): 

    Exciting jobs in Drug SafetyDrug Safety Coordinator:

    Responsible for the receipt and data entry of adverse event records following organizational standard operating procedures, internal business practices, and regulatory guidance documents to ensure compliance with worldwide safety regulations and corporate policies.

    Drug Safety Associate:

    A Drug Safety Associate is accountable for evaluating pharmaceuticals drugs safety once they’re on the market. Using standardized guidelines, they determine whether the medication causes any adverse reactions in patients and report their findings to the pharmacovigilance department.

    PV Officer: 

    PV officers liaise closely with drug and medical organization representatives, doctors, patients, and other healthcare specialists to record drugs and other practices’ effectiveness. The data is recorded, analyzed, and processed because pharmacovigilance officers’ informed opinions will help pharmaceutical corporations enhance product safety and performance and cut down on adverse effects.

    Drug Safety Scientist: 

    Prepare safety assessment reports and other safety documents and regulatory responses. Manage actions relating to the processing, follow-up, analysis, and regulatory reporting of adverse events (AEs) and serious adverse events (SAEs) for marketed and investigational products under the applicable regulatory requirements.

    Salary Range

    Gain the in-demand abilities you require to break into a new career in the Drug Safety with Sollers certification. No earlier experience is needed to get started. Tell us your goals, and we’ll match you with the right jobs. 

    Sollers College strives to support those who want to begin their career in the healthcare sector; healthcare professionals also attain mid-level positions with the help of the Certification program.  

  • Global Marketing Trends of Pharmacovigilance

    Global Marketing Trends of Pharmacovigilance

    The pharmacovigilance demand is expected to cross USD 10,881.03 Million by 2025 at a CAGR of 14.1%. The expanding prevalence of chronic conditions is exacted to drive the increase of the global market pharmacovigilance. Growing preference towards drug personalization stimulates the global pharmacovigilance market outlook in between 2019-2025.

    Rising adoption and acceptance of outsourcing services by healthcare companies will spur pharmacovigilance (PV) market growth during the upcoming years. Outsourcing dismisses the risk of market overhead costs as well as the deployment of pharmacovigilance support. Outsourcing strategy increases the cost-effectiveness and efficiency by relieving resource pressure of the manufacturing companies. Pharmacovigilance outsourcing shifting trends owing to growing benefits will accelerate to market expansion in the coming years.

    Global Pharmacovigilance Marketing Trends

     

    Market Drivers

    • Increasing the choice of outsourcing services
    • Growing technological improvements
    • The increasing ubiquity of chronic conditions
    • Increasing expenditure on oncology medicine and research
    • Massive spending by the pharmaceutical industry
    • Improving drug development and drug consumption rates
    • Increase in evidence of adverse drug reactions (ADRs) and medication errors
    • Patent expiration of branded drugs and an increasing number of new drug developments

    The demand for Drug Safety Scientists has increased with the need for professionals with Signal Detection, Risk Management, and Aggregate Report Writing experience. Pharmacovigilance is arguably one of the most challenging markets to recruit within the Life Sciences sector. 

    Therefore, it is not surprising that most agencies will have just one specialist looking at this area when there can be an army of recruiters working in Clinical, QA, Regulatory Affairs, etc.  It is necessary to pursue certification courses. With the help of Sollers, anyone can excel with all the required tools and technologies. Power your career with Drug Safety and Pharmacovigilance certification.

     

     

  • Why should you opt for a career in the Life Science sector?

    Why should you opt for a career in the Life Science sector?

    Research and development in the pharmaceutical field have always been treated as the heart of the business. There is no surprising factor that the pharmaceutical industry’s roles related to clinical research, drug safety, clinical trial, and data management are evolving and moving as the industry endure to embrace radical transformations. A solid understanding of these fields may put you ahead of the race.

    Need for Clinical talent:

    Are you in the clinical trial field looking for a break? It is worthy to assess the required skills to be on-trend. Optimize your probability of grabbing and sustaining employment in the fundamental and exciting department of work 

    There are specific skills that go with the territory of being in a pharmaceutical role such as deductive reasoning, critical thinking, attentive to detail. With the advent of technological advancements, companies restructure, and business practices, few desirable skills have been made into many employers’ wish lists.

     Is a Clinical Research Associate job for you?

    The primary responsibility of a Clinical Research Associate (CRA) is to monitor clinical trials’ progress. They usually involve visiting sites to ensure that protocols are being conducted in compliance with useful clinical practice guidelines.

    CRAs have highly diverse, visible positions. Mature interpersonal skills are essential to enable them to work well with the staff at the various sites they visit. Being friendly, professional, knowledgeable, punctual, and accessible, combined with a ‘checklist’ mentality, are good fit attributes. As CRAs principally work from home, evidence of being a motivated self-starter may attract employers’ attention.

    With regards to working in Drug Safety:

    At the grassroots level, drug safety experts are liable for the fielding and processing of adverse event records for drugs in the marketplace. It is their responsibility to recognize the risks associated with medicines and to make this information generally available. Like the RA professional, drug safety experts need to understand legislation and regulatory standards while overseeing pharmacovigilance (PV) processes. 

     How about Clinical Data Management?

    Clinical data managers are liable for assuring that clinical trials’ statistical information and results are recorded precisely and maintain complex data systems’ integrity and security. Expertise with IT, software systems, and generally managing vast volumes of data is therefore imperative.

    If you’re keen to seek a career in clinical data science, clinical research, and drug safety and pharmacovigilance but lack specific skills, it would pay to work towards obtaining or acquiring them. Providentially, many skills are transferable, so you don’t necessarily have to gain them in a clinical research setting. Sollers offers certificate and master programs to give you a leading-edge. 

  • Drug Safety and Pharmacovigilance: A Thriving Career Platform

    Drug Safety and Pharmacovigilance: A Thriving Career Platform

    Drug Safety and Pharmacovigilance radically transforming the future of the Pharmaceutical industry. The healthcare sector’s never-ending progress has resulted in modern medicines’ availability to prevent efficiently, control, and manage disease state. Renowned focus emerges for more direct involvement of patients and treatments. Despite many benefits, medicines’ adverse reactions are not uncommon, and those are associated with most newly developed drugs. Hence the Drug Safety and Pharmacovigilance field is always a front runner and plays a massive role in improving and promoting public health.

    The Drug Safety and Pharmacovigilance market’s current trends are in conjunction with the demanding scope, remuneration scale, geographical landscape, and growth graph of this vertical have also been included in this report. The volume and speed of clinical research to discover effective drugs against novel coronavirus has been remarkable. The governance is made flexible and convenient without any leisure in drug safety reporting to address the unmet medical need.

    It is imperative evidence that in COVID days, the pharmacovigilance activities, particularly adverse event reporting, should remain as usual as patient safety is the priority despite clinical practice or clinical trials. The susceptibility to experimental drugs with limited evidence of risk-benefit makes it numerous crucial to adopt accuracy in adverse event reporting, timely assessment, and vital safety monitoring.

    The main goals of Drug Safety and Pharmacovigilance are

    • Identify the risks associated with the use of medicines by the patients.
    • Perform a comparative assessment of potentially beneficial and adverse effects of the drugs and help optimize the nature of service.
    • Promote the effective, safe, and wise use of medicines.
    • Improve awareness among patients and the general public regarding the safe use of drugs via effective communication.

    Pharmacovigilance is ingrained, with several departments and rightly so, in several healthcare management areas. Drug Safety and Pharmacovigilance programs in clinical practice help healthcare professionals continuously update and remain current on the knowledge base related to medicines’ adverse outcomes.

    With the growing drug consumption, the requirement for the regular monitoring of drugs has also expanded, gradually boosting the Drug Safety and Pharmacovigilance demand. Human infectious diseases are also increasing due to pervasive poverty, uncertain climate changes, and increasing urbanization, which again surge the drug consumption and drive the drug development process.

    Drug Safety and Pharmacovigilance is a thriving platform for lucrative careers for life science and pharmacy graduates. We are privileged to be in a position where we can make a material difference by providing several certification programs in the Life Science sector. Students attain knowledge of adverse drug reactions, adverse events, reporting guidelines, ICSR processing, etc.

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