Sollers College

Tag: Aggregate reporting in Pharmacovigilance

  • Aggregate Reporting in PV: What It Is and Why It’s a Must-Know for Global Pharma Careers

    Aggregate Reporting in PV: What It Is and Why It’s a Must-Know for Global Pharma Careers

    In the ever-evolving world of pharmacovigilance (PV), aggregate reporting stands as a cornerstone of drug safety. As the pharmaceutical industry expands globally and regulatory requirements tighten, professionals trained in aggregate reporting are increasingly in demand. But what exactly is aggregate reporting, and why is it critical for anyone pursuing a career in drug safety?

    Understanding Aggregate Reporting in Pharmacovigilance

    Aggregate reports are comprehensive documents that summarize the safety profile of a drug over a defined period, typically combining data from multiple sources such as spontaneous reports, clinical trials, and published literature. These reports help regulators and pharmaceutical companies detect trends, and emerging safety issues, and assess risk-benefit profiles.

    The most common types of aggregate safety reports include:

    Periodic Benefit-Risk Evaluation Reports (PBRERs) – An internationally standardized format that has largely replaced the traditional PSUR under the ICH E2C(R2) guideline.

    Periodic Safety Update Reports (PSURs) – Still used in some regions, but often referred to as PBRERs in the current regulatory landscape.

    Development Safety Update Reports (DSURs) – These are required during the clinical development phase of a drug to monitor safety in ongoing clinical trials.

    These reports are required by health authorities like the FDA (U.S.), EMA (Europe), and other regulatory bodies worldwide.

    Why Is Aggregate Reporting So Important?

    Aggregate reporting ensures that drug manufacturers maintain transparency and accountability throughout the lifecycle of a pharmaceutical product. It helps prevent adverse events, protects patient safety, and maintains compliance with global regulations.

    Here’s why you must pay attention to aggregate reporting if you are entering the field of pharmacovigilance:

    • Career Relevance: Most global pharmacovigilance roles, from safety officers to regulatory specialists, require a strong grasp of aggregate reporting.
    • Global Standardization: Aggregate reporting is recognized and mandated by international regulatory authorities, opening doors to global career opportunities.
    • Real-World Impact: Your work directly contributes to safer medication use worldwide.

    Current Industry Trends & Market Insights

    The demand for skilled pharmacovigilance professionals has been rising steadily due to increased drug development and stricter regulatory scrutiny.

    Global Market Projection: The pharmacovigilance market is expected to reach USD 13.9 billion by 2030, growing at a CAGR of 11.5% from 2023. (Source: Grand View Research)

    Growth in PV Roles: Job postings related to pharmacovigilance and drug safety reporting have increased by over 25% in the last 2 years on platforms like LinkedIn and Indeed.

    Average Salary: Entry-level roles in aggregate reporting start at $60,000/year, while experienced professionals can earn up to $120,000/year, depending on location and qualifications. (Source: Glassdoor)

    Global Reach: With regulators like the European Medicines Agency (EMA) and U.S. FDA mandating standardized safety reports, aggregate reporting professionals are now integral to global pharmacovigilance operations.

    Get Trained and Future-Ready

    At Sollers College, our specialized programs in Drug Safety and Pharmacovigilance include comprehensive training in aggregate reporting. You’ll gain practical exposure through real-world case studies, tools, and hands-on reporting simulations.

    Whether you have a background in life sciences, nursing, pharmacy, or medicine, learning aggregate reporting equips you with in-demand skills that pharma companies are actively seeking.

  • Difference between Drug Safety and Pharmacovigilance

    Difference between Drug Safety and Pharmacovigilance

    Pharmacovigilance vs. Drug Safety

    Drug Safety & Pharmacovigilance are receiving more attention than any these days. “Drug Safety and Pharmacovigilance” is not a single term. There is a slight difference between “Drug Safety” and “Pharmacovigilance.”

    Drug Safety: Drug Safety focuses on the rigorous examination and reporting of data gathered from clinical trials and post-marketing environments. This discipline emphasizes compliance and regulatory reporting. Regulatory agencies use this data to make informed decisions about drug registration, while reimbursement authorities assess the risk-benefit profiles of treatments.

    Pharmacovigilance: Pharmacovigilance extends beyond traditional Drug Safety by adopting a proactive approach. It involves vigilant monitoring of drugs in real-world settings, aiming to detect signals and trends early. This model utilizes advanced data analytics to analyze large, complex datasets, providing insights into drug performance across diverse patient populations and disease states.

    In short, we can say one is reactive, and the other is proactive. One is taking care of compliance and reporting, and the other is focused on interpreting signals. Ultimately, both refer to the same function of reporting, gathering, and adverse drug reactions. The primary difference between Drug Safety and Pharmacovigilance lies in the value of data generation. 

    Key Difference between Drug Safety and Pharmacovigilance

    Drug Safety  Pharmacovigilance

    With the Drug Safety design, data collected at clinical trials and in the post-marketing environment is examined and reported.

    Crucial data is highlighted, and regulatory agencies use this information to decide which drugs will be registered and reimbursement authorities to decide reimbursement. 

    These choices include weighing up the risk vs. benefit of different treatment options, i.e., for the service that the patient receives from the medicine, what are the likely chances in terms of side effects.

    		 The Pharmacovigilance model takes drug safety to the next level. The term ‘vigilance’ links to ‘being vigilant,’ i.e., proactively considering the environment, and identifying signals and trends, with an enhanced focus on the post-marketing environment. 

    The conditions of use have changed. Patient compliance is variable, and inclusion/exclusion criteria are not as tight as in controlled trial settings. 

    Within the Pharmacovigilance model, larger and more complex datasets are being analyzed.

     It generates considerable insight into how drugs are performing in the real world. 

    Valuable data is being developed on how medicines are completing inpatient sub-populations and across disease states.

    The Pharmacovigilance model concentrates on establishing signal detection systems and uses advanced data analytics to proactively monitor the entrance of new medicines to large patient populations. Real-world evidence is collected, collated, analyzed, and turned into penetration which is then being used during regulatory, reimbursement, and commercial discussions on strategic competitive benefits.

    Both Drug Safety and Pharmacovigilance serve critical roles in ensuring medication safety. While they share the fundamental goal of monitoring adverse reactions and ensuring drug efficacy, Pharmacovigilance goes beyond, using comprehensive data to inform strategic decisions in healthcare.

    difference between drug safety and pharmacovigilance

    Certification in Drug Safety and Pharmacovigilance:

    This Drug Safety and Pharmacovigilance certification not only shows that you have the expertise needed for the job or the project, but certifications also showcases your dedication towards what you do, giving credible proof that you have full fledged knowledge on the topic. In addition, certification shows that you are fully committed to your career besides validating that you maintain the latest information and know-how of the tools when doing your job.

  • What challenges and opportunities lie ahead for pharmacovigilance in the future?

    What challenges and opportunities lie ahead for pharmacovigilance in the future?

    The pharmacovigilance trend is expected to become more prominent in the coming years.

    In times of public health emergencies, pharmacovigilance and risk communication are essential.

     In addition, machine learning techniques and access to large amounts of electronic healthcare data provide opportunities for improving the assessment of the drug benefit-risk profile in real-world settings. 

    Finally, innovative therapeutics have been marketed more frequently in recent years. Examples include medicines for advanced therapy, digital therapeutics, and vaccines created using advanced technologies. These medicines require special pharmacovigilance monitoring.

    Pharmacovigilance is a critical aspect of the pharmaceutical industry that ensures drug safety and efficacy. It involves the detection, assessment, understanding, and prevention of adverse effects or other drug-related problems. As technology advances, pharmacovigilance faces both challenges and opportunities. 

    Challenges:

    Big Data: One of the most significant challenges facing pharmacovigilance is big data management and analysis. With the increasing volume of data generated from electronic medical records, social media, and other sources, it becomes difficult to extract relevant information and identify potential safety issues.

    Regulatory Changes: The regulatory landscape for pharmacovigilance is continually evolving, and keeping up with the changes can be challenging. Changes in regulations may require changes to data collection, reporting, and analysis methods, which can be time-consuming and expensive.

    Globalization: The globalization of the pharmaceutical industry means that pharmacovigilance needs to be carried out across multiple jurisdictions, each with its own regulations and reporting requirements.

    Adverse Events Reporting: Adverse event reporting is a vital part of pharmacovigilance, but it can be challenging to ensure accurate and complete reporting. Patients may not always report adverse events, and healthcare providers may not always recognize or report them.

    Opportunities:

    Artificial Intelligence: Artificial intelligence (AI) can help in pharmacovigilance by analyzing large amounts of data quickly and accurately, detecting trends and patterns, and identifying potential safety issues.

    Patient Engagement: Engaging patients in pharmacovigilance can improve adverse event reporting and increase patient safety. Patients can be educated on the importance of reporting adverse events and how to do it.

    Digital Health: Digital health technologies such as wearable devices, mobile apps, and telemedicine can help with pharmacovigilance by monitoring patients in real-time and detecting adverse events early.

    Real-World Data: The use of real-world data (RWD) can provide valuable insights into drug safety and effectiveness in real-world settings. RWD can complement clinical trial data and provide a more comprehensive understanding of a drug’s safety profile.

    Future Trends and Major Constraints


    Study participants are typically selected based on strict eligibility criteria, leading to difficulties when conducting studies. Adverse reactions may not be identified long-term in these patients because they are not representative of the actual population.

    The post-marketing medicine evaluation process will make it easier to define the safety profile of any drug in a practical setting.

    ML and AI may also improve pharmacovigilance by automating case report entries, identifying clusters of adverse events, and conducting pharmaco-epidemiological studies.

    Using multiple models to predict negative outcomes and prevent them, as well as linking data using the probabilistic matching technique across datasets, are additional benefits.

    With the right AI and ML techniques, many of the upcoming challenges relating to data from multiple sources, faster processing, and perhaps forecasting with accurate models may be resolved.

    What challenges and opportunities lie ahead for pharmacovigilance in the future?

    Conclusion

    Pharmacovigilance is a critical component of the pharmaceutical industry, ensuring drug safety and efficacy. As technology advances, pharmacovigilance faces both challenges and opportunities. Artificial intelligence, patient engagement, digital health, and real-world data are some of the opportunities that can help overcome challenges and improve pharmacovigilance.

     However, regulatory changes, big data, globalization, and adverse event reporting continue to be challenges that need to be addressed. By embracing cutting-edge technologies and adopting a patient-centric approach, pharmacovigilance can continue to evolve and improve patient safety.

    Sollers College’s certificate program in pharmacovigilance aims to provide students with a comprehensive understanding of pharmacovigilance principles, processes, and regulations.

    Students will also gain hands-on pharmacovigilance experience by participating in case studies, group discussions, and practical exercises.

    The certificate program in pharmacovigilance at Sollers College is designed for individuals with a background in life sciences, pharmacy, or healthcare. Their goal is to develop their pharmacovigilance skills. The program is available online, and accessible to students worldwide.

  • Future challenges for PV in the monitoring of adverse drug reactions

    Future challenges for PV in the monitoring of adverse drug reactions

    As defined by the World Health Organization, adverse drug reactions are unintended and detrimental side effects caused by drugs that have been prescribed to treat a diagnosed illness. It is important to raise patient awareness of ADRs as they are widely accepted in developed and developing nations alike.
    New drugs are continuously monitored by pharmacovigilance centers to assess their side effects and safety.

    A series of steps called pharmacovigilance aims to recognize, comprehend, and evaluate the risks connected to the use of medications. Furthermore, they take steps to reduce the side effects of the drugs. Drug surveillance involves two phases: pre- and postmarketing pharmacovigilance.

    A sufficient understanding of the drug’s side effects is required to promote effective drug use in the population, which includes various patient groups such as the elderly, children, and patients with diseases. Successful pharmacovigilance programs running on that drug can accomplish this.

    Pharmacovigilance serves several functions, including identifying, observing, evaluating, and documenting drug-related issues and comprehending the factors causing unfavorable effects.

    Adverse drug reaction reports

    Drugs have nearly doubled their negative effects in the last decade. The severe side effects of medications have led to the discharge of a large number of patients.

    The ADR document’s specifications

    The global pharmacovigilance education system encourages the documentation of all alleged adverse drug reactions. The following reports are of interest to it:

    (A) Each negative effect that has been reported or experienced about brand-new medications as well as recently released medications
    (B) Congenital abnormalities, deaths, and life-threatening illnesses have all been reported because of adverse drug reactions. 

    Any significant adverse drug reaction should be reported within seven days. Within eight days, the other details surrounding the unfavorable events should be disclosed. Any pharmacovigilance center will be able to provide you with the ADR form. The peripheral pharmacovigilance center can receive the completed ADR form.

    ADR reporting process

    Reporting any suspected adverse drug reactions is the first responsibility of pharmacovigilance centers.

    tracking of ADRs


    ADR monitoring is defined as the practice of continuously tracking the side effects brought on by taking any medication. Pharmacovigilance is crucial to the role of ADR monitoring.

    ADRs may develop while using a range of pharmaceuticals, herbal remedies, cosmetics, medical devices, and biological products, among others. During this monitoring process, safe and effective medications will be provided to patients.


    If adverse events are not disclosed, remedial products may have unpleasant and negative effects. ADR monitoring programs must be properly implemented to reduce the adverse effects of therapeutic products.

    ADRs may develop while using a range of pharmaceuticals, herbal remedies, cosmetics, medical devices, and biological products, among others. Through this monitoring process, it will be ensured that patients receive safe and effective medications.

    Advantages of ADR surveillance


    The following advantages can be obtained from an ADR monitoring and reporting program:


    1.  It provides details on the reliability and security of pharmaceutical products.
      2. Plans for risk management are started.
      3. It helps in measuring the incidence of ADRs and prevents predictable adverse effects.
      4. It raises awareness of ADRs and educates the healthcare team, patients, pharmacists, and nurses about adverse drug reactions.
      ADR monitoring’s primary goals are to identify the risk factors that can result in adverse reactions as well as disclose the type, quantity, and frequency of ADRs.

    Studies for the detection of adverse events are included in ADR monitoring.
    Type-B adverse drug reactions, which are unpredictable, are reported in case reports.

    First-hand accounts
    When a patient experiences a particular effect, reports from specific doctors are used for this type of reporting.

    Spontaneous reporting system

    1. a. This is regarded as the most effective approach.
       This approach is used by all ADR reporting programs. Effects are captured voluntarily in this instance.
      c. Both uncommon and urgent ADRs can be targeted and tracked using this approach.
      d. Research on intensive monitoring
      f. Every time a drug or combination of drugs is administered, healthcare professionals continuously monitor the patients and log everything they see. ADRs are found by screening specific patient groups.

    Anecdotal evidence


    When a patient experiences a specific effect, reports from specific doctors are how this type of reporting is generated.
    system of impulsive reporting
    This approach is thought to be the most effective one.
    Almost all ADR reporting programs adhere to this process. In this case, the effects were captured voluntarily. This approach can be used to monitor and target unusual and acute adverse events.

     Extensive monitoring studies 


    When a drug or several drugs are administered, healthcare professionals continuously monitor the patients and log every event they see. In this, predetermined patient groups are screened to look for ADRs. The main drawback of these studies is that each patient is only studied for a brief amount of time, and the population only consists of a small number of patients.

    Variable studies
    Patients receiving similar medications are identified, and their events are noted in these studies. The minimal number of patients included in this method and the absence of a control group for comparison are its main drawbacks. The contingent examinations are too expensive, and it is challenging to carry out these tests on recently marketed drugs.

    A case-control study
    In these studies, patients who have a disease brought on by drug use are examined to see if they have taken the drug. Then, these patients are contrasted with a control group that is matched to them and shares many confounding factors but is free of adverse events.
    This is an effective way to determine whether the drug was the root cause of the adverse event or not.

    Outcomes

    ADRs could potentially cause patients to experience negative outcomes. ADRs in patients are increasingly being recognized by healthcare professionals and pharmacovigilance professionals. The study’s findings can help doctors use the techniques to recognize ADRs in patients.

                            Graduates of Sollers benefit from more than just their degrees. 

    Students receive comprehensive job search assistance through our career services and industry partnerships. 

    Identify and create capabilities-based training curricula for future jobs. Industry experts work with business partners to develop the curriculum for each program.

     

     

     

  • 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.

  • 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!

  • 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. 

  • 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.

×