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Pharmacovigilance Training

Pharmacovigilance course provided Ramya at Great Online training. Pharmacovigilance Training included real time project and ARGUS safety data base. Pharmacovigilance course tutorial for all students who are looking career in this area.

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    Brief details of this course training

    Name of the Course Pharmacovigilance Advanced Course
    Duration 45 days / 1 hr per day
    Training Days Monday to Friday(EST)
    Course Materials Videos, Books

    Enroll for Pharmacovigilance Self-paced Course


    • GBP: £50
    • INR: ₹5,000
    • CAD: $83
    • SGD: $81
    • EUR: €56

    Overview of Pharmacovigilance

    Medicines are chemicals or compounds used to cure, decrease or prevent disease, ease symptoms or help in the diagnosis of illness. Consuming a medicine is equivalent to consume a risk, because no medicine is absolutely safe and all pose some health risks. These risks are mild in most cases but have the potential to cause disability or even death. The decision whether medicine can be taken or not depends on benefits and risks ratio. The product will be available in market if the benefits associated with medicine outweigh the risk. Hence drug safety monitoring and risk management are vital for manufacturers and regulatory authorities. Pharmacovigilance also known as drug safety, is the process that make sure the medicines are safe for their intended use, which starts at drug development phase and continues through out life cycle of the product.


    As per world health organization (WHO), Pharmacovigilance is the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problem.

    Pharmacovigilance Interview Questions by Ramya

    Aims of Pharmacovigilance:

    1. To improve patient care about drugs and keep the patient safe from adverse effects of medicines, and all medicinal and paramedical interventions.
    2. To contribute to the assessment of benefit, risk and effectiveness of medicines.
    3. To promote understanding, education and training about this field and its effective communication to health professionals and public.
    4. To encourage safe and rationale use of medicines.

    Objective of Pharmacovigilance:

    1. To detect the new adverse effects, drug interactions and contraindications.
    2. Communication of information about adverse events so that they occur less frequently.
    3. Reevaluation of risks and benefit ratio for effective use of medicines in patients to reduce side effects and more benefits.
    4. Identification of mechanisms that cause adverse effects of drugs.

    Pharmacovigilance process - Adverse event process flow

    The pharmacovigilance process includes multiple phases of handling adverse event report. Phase 1: Collection of all adverse event reports including serious, non serious, new or already known event. Adverse event reports are collected through different sources which are;
    1. Spontaneous or voluntary reports
    2. Clinical trials and Post marketing study Reports
    3. Literature reports
    4. License partner reports
    5. Regulatory authority reports
    6. Legal reports
    Phase 2: includes assessing these adverse event reports as per pharmacovigilance process guidelines and submitting them to regulatory authorities. In this phase the drug safety team assess the information multiple steps:
    1. Case validity assessment
    2. Database entry
    3. Event selection and coding with MedDRA
    4. Product coding
    5. Seriousness assessment
    6. Causality assessment
    7. Labelling assessment
    8. Writing narratives
    9. Medical input
    Phase 3: determine the specific adverse events associated with medicines and then compare with another drug having similar adverse effect. Multiple teams involved in this phase.
    1. Periodic report compilation/aggregate reporting
    2. Signal management
    3. Risk-benefit assessment
    Phase 4: Management and communication of these adverse effects.

    Students Testimonials on  pharmacovigilance Course

    Basic fundamentals of ICSR

    Individual Case Study Report (ICSR) is an adverse event report for an individual patient and is source of data in pharmacovigilance.

    Sources of AE reporting:

    1. Spontaneous or voluntary reports - As per ICH E2D, A spontaneous report is an unsolicited communication by healthcare professionals or consumers to a company, regulatory authority or other organization (e.g. WHO, Regional Centers, Poison Control Center) that describes one or more adverse drug reactions in a patient who was given one or more medicinal products and that does not derive from a study or any organized data collection scheme.
    2. Clinical trials and Post marketing study Reports - The Adverse events reported while patient participating in clinical trials or post marketing trials.
    3. Literature reports - Literature report is any adverse drug reactions reported in
      1. Published abstracts or
      2. Articles in medical/scientific journals
      3. Unpublished manuscripts involving case reports
      4. Important safety findings or clinical studies including posters, letters to the editors, and associated communication from scientific meetings.
    4. License partner reports - A Pharma company get into a licensing agreement with third party to produce or market a drug formulation that the other company has developed. Each license partners does have pharmacovigilance agreement to meet safety requirements in marketing country. The cases received from other pharmaceutical company which has PVA agreement are handled as license partner cases.
    5. Regulatory authority reports - If a consumer or healthcare professional directly report adverse events to regulatory authority (i.e, FDA, EMA etc..) not to marketing holder (pharmaceutical company), then those reports will be shared to marketing holders by regulatory authorities. This type of cases which were received by companies from regulatory authority are handled as regulatory authority cases.
    6. Legal reports - If the reporter file a lawsuit against medicine manufacturer and the report received from the lawyer are handled as legal case.
    ICSR Validity: All the adverse event reports may not be valid. Only valid reports which meets below criteria are to be submitted to Regulatory authority.
    1. Identifiable patient
    2. Identifiable reporter
    3. A suspect drug
    4. An adverse event or adverse drug reaction

    Types of ICSR reports:

    Based on source of adverse events the ICSRs are categorized into solicited and non-solicited reports.
    1. Solicited Reports are the ICSRs which were originated from a organized data collection system such as;
      • Interventional and non interventional clinical trials
      • Patient registries
      • Post marketing studies
      • Patient support programs
      • Marketing programs
      • Investigator initiated trials
      • Compassionate use programs
    1. Non solicited reports are the ICSRs which originated from unorganized data collection system such as;
      • Literature cases
      • Legal reports
      • Regulatory authority reports
      • Spontaneous reports
      • Social medial reports

    Steps involved in ICSR:

    Once the report received from one of the sources mentioned above, the case undergoes multiple processing steps before submitting to regulatory authorities. The steps involved in ICSR case processing are:
    1. Case validity assessment
    2. Database entry
    3. Event selection and coding with MedDRA
    4. Product coding
    5. Seriousness assessment
    6. Causality assessment
    7. Labelling assessment
    8. Writing narratives
    9. Medical input

    Regulatory submission timelines:

    Globally ICSR are reported under 3 categories :
    1. Clinical Death/Life threatening cases and SUSAR (Suspected Unexpected Serious Adverse Reaction) cases are reported within 7 calendar days to the NCA (national competent authorities)/HA (health authorities).
    2. Clinical trial other Serious cases and safety issues are reported in 15 days calendar days timeframe.
    3. Serious post marketing cases are reported within 15 calendar days to the NCA (national competent authorities)/HA (health authorities)
    4. Non-Serious cases are reported within 90 calendar days to the EU health authority (EMA). Not mandatory for non-EU countries.
    The clock starts (day 0) on the date when any personnel of the MAH first receive a case report that fulfill the minimum criteria

    Basics of Aggregate reporting

    Aggregate reporting is the process that reviews the cumulative safety information from a wide range of sources, on a periodic basis and submits the findings to regulators worldwide.

    Types of aggregate reports:

    • Pre-marketing report:
      • IND annual reports
      • Clinical study reports (CSR)
      • Development Safety Update Report (DSUR) (annual reports)
    • Post-marketing report:
      • Periodic Benefit Risk Evaluation Report (PBRER)/Periodic Safety Update Report (PSUR)
      • Periodic Adverse Drug Experience Report (PADER).
      • NDA and ANDA annual reports

    Signal Management

    The definition of a signal as provided by the Council for International Organizations of Medical Sciences (CIOMS) 8 Working Group: Information that arises from one or multiple sources (including observations and experiments), which suggests a new potentially causal association, or a new aspect of a known association, between an intervention and an event or set of related events, either adverse or beneficial, that is judged to be of sufficient likelihood to justify verificatory action. Signal Management: A set of activities performed to determine whether, based on an examination of individual case safety reports (ICSRs), aggregated data from active surveillance systems or studies, scientific literature information or other data sources, there are new risks associated with an active substance or a medicinal product or whether known risks have changed, as well as any related recommendations, decisions, communications and tracking. Activities include:
    • Signal detection
    • Signal validation
    • Signal prioritization
    • Signal assessment
    • Recommendation for action
    • Exchange of information

    What type of jobs are there in Pharmacovigilance and which one I should consider?

    There are multiple areas in pharmacovigilance, some need specialization and some need medical/clinical/pharmacology knowledge. Core pharmacovigilance team require medical/clinical/pharmacology knowledge. This team handles ICSR reports, aggregate reporting, signal management, preparing RMPs/REMS/SMPs. These jobs require qualification of healthcare professional (physicians, nurses, pharmacists, dentists, veterinarians, Ayurvedic physicians). At an entry level one can apply for drug safety associate role who handles ICSR reports. There are multiple roles in ICSR such as case intake/triage team, case processing, quality review and medical review. Medical review team requires physicians but other teams need healthcare professionals. To apply for this role one must have knowledge in pharmacovigilance processes and guidelines, must have skill set to read incoming hospital records, patient records, medical literature, case report forms, labelling documents etc. Major activities that are reading medical records or patient adverse event reports, writing narratives, event coding with MedDRA, product coding with WHODD, event seriousness assessment, labelling and causality assessment, entering data into drug safety database like ARGUS, ArisG etc., Starting level job titles are:
    • Pharmacovigilance specialist
    • Pharmacovigilance scientist
    • Drug safety associate
    • Safety and pharmacovigilance associate
    • Signal detection drug safety associate
    At an entry level for drug safety associate the average salary range can be between 300K - 400K per annum for other healthcare professionals and for physicians the starting salary is 800K per annum. Once you have achieved 2-3 years of experience you can move forward to either quality review, signal management or if you have good narrative writing background you can move into aggregate reporting where you will be writing many different types of reports such as expedited reports, DSUR, PBRER, PADER, RMPs, REMS, Annual safety reports etc. The specialist jobs in pharmacovigilance include; statisticians (requires masters in statistics or biostatistics), epidemiologists (requires PhD in epidemiology or relevant field), IT and computer experts.

    Job offering Organizations on the Globe

    Each and every pharmaceutical company has their own pharmacovigilance team as it mandatory as per regulatory requirements/WHO/ICH. In large pharmaceutical companies, more than 100000 adverse event reports can be received each year.  To handle the cases effectively and to meet the regulatory timelines and compliance, companies started outsourcing the PV unit. Trained Pharmacovigilance associate can apply for employment opportunities in the following organizations:
    1. Pharma and biotech companies
    2. Contract research organizations (CROs)
    3. Knowledge process organizations (KPOs)
    4. Regulatory authorities
    There are many CROs and KPOs are handling PV for many big pharma companies in India and there are many pharmacovigilance consultancies available in USA and EU regions. Top CROs/KPOs/consultancies hiring pharmacovigilance jobs are:
    • Accenture

    • Cognizant

    • TCS

    • IQVIA

    • Parexel

    • Kinapse

    • APCER life sciences

    • PPD

    • Bioclinica

    • Tech Mahindra

    • Pharmalex

    • Primivigilance

    Pharmacovigilance FAQs

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    This Course Features

    Unlimited training Attempts

    Pay once and get life-time training access

    Daily Class Recordings

    Get life-time access for daily class recordings along with training

    24/7 support

    Support available for 24/7

    Resume and Interview Preparation

    Help in resume and interview preparation along with training

    Course Curriculum

      • Introduction to PV Unlimited
      • Brief history of PV Unlimited
      • Importance of adverse event reporting Unlimited
      • Reasons for ADR collection Unlimited
        • Introduction to Individual case safety report (ICSR) Unlimited
        • Basics of Aggregate Reporting Unlimited
        • Basics of Signal Management Unlimited
        • GVP Modules training Unlimited
        • Eudravigilance requirements Unlimited
        • FDA Good Pharmacovigilance Practices and Pharmacoepidemiologic Assessment Unlimited
        • FDA regulation for IND safety reporting and post market safety reporting Unlimited
        • Sources of ADR reports Unlimited
        • ADR validity assessment Unlimited
        • Adverse event selection, coding and Basics of MedDRA Unlimited
        • Assessing ADR reports – Seriousness, labelling, causality and Narrative writing Unlimited
        • Workshop on Labelling, causality and narrative Unlimited
        • Event selection and coding Unlimited
        • MedDRA training and workshop Unlimited
        • Case follow-up Unlimited
        • Duplicate search process and handling duplicates Unlimited
        • Reports of Special situation Unlimited
        • PBRER Unlimited
        • PADER Unlimited
        • DSUR reports Unlimited
        • Signal detection process Unlimited
        • Signal prioritization Unlimited
        • Signal evaluation and validation Unlimited
        • Signal Analysis Unlimited
        • Signal Assessment Unlimited

            Course Reviews

            1. Sumitra Sumi10/07/2021 at 8:12 am

              Great Online Training is a good platform to start from basics


              Great Online Training has excellent trainers and pharmacovigilance trainer is one such trainer. Her training is very interactive and informative, Great Online Training is a good platform to start from basics, Thank you.

            2. Tanvi Nemane10/07/2021 at 8:10 am

              Got job in reputed MNC after this training


              I got completed the course by Great online training with pharmacovigilance. I took decision to join classes just by watching free open video on YouTube. Trust me it was the best decision I made. I finally got job in reputed MNC and believe me great online training has the best teacher to teach Pharmacovigilance and acquire knowledge with great skill. Thank u once again Great Online Training

            3. previous videos have inspired me to join the class


              I have attended Pharmacovigilance online classes. Its previous videos have inspired me to join the class and the trainer is patient in attending to each and everyone’s doubts. It’s been the best experience of attending an online class. Thanks to Great Online for encouragement and all the resources shared are unique. I am not sure if any other online program would share so much with their students. Thank you once again!!

            4. Sandeep Yadav10/07/2021 at 8:01 am

              Highly recommend the classes to everyone


              Switching to new career is always very scary. But, in my case I am fortunate to have Great Online Training. Who has given me confidence in the second class itself, that even I can make my step in Pharmacovigilance. Very good at explanation and at clearing doubts. So, planning to take future classes whatever the trainer has planned for this course. I Highly recommend the classes to everyone to shape up their career in Pharmacovigilance. All the best.😃

            5. Manoj Padhyar10/07/2021 at 7:56 am

              One of the best leaning platforms you will ever come across


              It’s one of the best leaning platforms you will ever come across. The trainers give individual attention to students and makes you comfortable with the subject. Thank you Great Online Training 🙂

            6. Whoa. It was an incredible course


              Whoa. It was an incredible course and covered almost everything one will ever need to succeed as a Drug safety officer. The trainer did an incredible job in the presentation and explaining everything through hands-on. Condensing it in only 8 weeks seems a bit much though

            7. Asajyothi Jyothi10/07/2021 at 7:28 am

              Became a professional from zero knowledge


              I would highly recommend this course to those who are passionate about learning Pharmacovigilance without any knowledge and experience and who want to utilize the Pharmacovigilance skill in their professional settings.

            8. Anthony Omoruy10/07/2021 at 7:21 am

              Best tutorial on the web


              I have zero knowledge of pharmacovigilance and the way you are teaching is AMAZING!!! You make
              it so interesting. Thanks a million for your effort and sharing your immense knowledge with the
              world! Best tutorial on the web! Thank you very much!

            9. Abhilash Sharon10/07/2021 at 7:06 am

              Great Pharmacovigilance real-time training


              There is a plethora of online training material available for Pharmacovigilance. But the rare
              combination of great instructors and comprehensive course material is the reason I chose Great
              Online Training. The course has a clear direction, which is perfect for efficiency-oriented
              professionals like us! They bring a lot of corporate experience on the table, which differentiates
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            10. A Praveen Kumar10/07/2021 at 5:56 am

              Best place to learn pharmacovigilance


              Great Online Training is the best place to learn pharmacovigilance training

            11. Saikumar Sai10/07/2021 at 8:07 am

              The trainer is very passionate about the teaching


              When I first searched about Pharmacovigilance training classes online, I found Great Online Training videos. The moment I listened to them I knew that was it!!!!! I joined the course immediately and I am completely satisfied with the training. The trainer is very knowledgeable and patient and very good about explaining the concepts thoroughly. She tries to answer all the questions you might have to the maximum extent possible. I am very confident about PV now after taking her classes despite of having science background. I would recommend to any one wanting to learn Pharmacovigilance. The trainer is very passionate about the teaching, she tries to update the materials and finds new ways to teach students.

            12. Prashant Malavadkar10/07/2021 at 7:58 am

              The customer support is of great help


              I have enrolled in the Pharmacovigilance from Great Online Training. I got to learn many new things. Their content is good and can be easily understood. The customer support is of great help. They helped me a lot with their technical skills. Great Online Training helps you in your studies and if you need help, you’re just a call/message away. Happy Learning!

            13. Komal Jaswal10/07/2021 at 7:54 am

              Very good real-time application


              Great presentation of complex material, exercises and quizzes really help with understanding and applying concepts in real time.

            14. Himabindu Adepu10/07/2021 at 7:51 am

              Great Online Training is committed towards training people better


              Great Online Training is committed towards training people and they made learning very easy. Trainers are having in-depth subject knowledge and it helps the learners very well in getting their queries clarified.

            15. Digisha Patel10/07/2021 at 7:47 am

              The course orientation and topic insight were very informative


              The Tutorial was nice. The course orientation and topic insight were very informative. I would suggest this Pharmacovigilance tutorial to my colleagues. Thanks to the trainer for making this course so interesting.

            16. Great online training is a great platform for Pharmacovigilance


              As the name itself indicates great online training is a great platform for people who are aiming to become a Pharmacovigilance officer/Drug safety officer. Great Online Training trainers are excellent in their own way of explaining the concepts

            17. Chaulaben Laben10/07/2021 at 7:31 am

              Very good trainer for pharmacovigilance


              I have taken the Pharmacovigilance recently (after watching the videos on YouTube) with Great Online Training. Trainer was very good in teaching and answering the questions. Covered all the topics in the view of Certification and Real time. It is recommended to have the training with Great Online training without any thoughts.

            18. Excellent course content


              The Pharmacovigilance course content is excellent and you can easily learn and understand, even if
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            19. Absolutely loved this course


              Absolutely loved this course. It not only helps me build a fundamental understanding of
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              Sometimes I only know how to do it without considering why is each step essential. Thank you
              again, Great Online Training. You have amazing instructors.

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