Certificate course in Pharmacovigilance

“An incident is just the tip of the iceberg, a sign of a much larger problem below the surface-Don Brown”

Our certificate course in Pharmacovigilance provides solid fundamental and deeper understanding of pharmacovigilance and helps the trainees to understand the goal of pharmacovigilance- to ensure safe use of medicines, minimizing the risks related to the medicinal product and maximizing the benefits. Safety assessment of a drug or device starts while the product is in the development phase and continues till the product is in the market. An in-depth understanding of the regulatory and scientific requirements is essential for anyone who wants to enter into the field of pharmacovigilance and make a career.

Learning Objectives
After taking this course, you should be able to understand -
  • The basics of Pharmacovigilance (PV) and career opportunities in the domain.
  • PV structure and process of collection and reporting of adverse events.
  • Case processing, database overview-Argus ,Special situations, causality assessment and signal management process.
  • Introduction to various safety aggregate reports like PBRER/PADERS/PSUR/RMP/REMS.
  • Eligibility criteria:
    Undergraduates, graduates and post-graduates of life sciences stream, pharmacy, biotechnology, dental, physiotherapy and paramedical courses and MBBS/MD.
    Training mode:
    The course is available as online and classroom options both with our training centers at Gurgaon and Pune, India. The classroom sessions are held twice a week and for the online courses we have one Skype session every week to discuss the queries and doubts and monitor the progress of the course.
    The ideal duration is for 2months but one can expedite the course after submitting the assignments and the complete access will be available for 6 months.
    Expected CourseHours/week:
    Weekly 6 hours
    Ongoing assessment after completion of content each week.
    Expected Outcomes:
  • Learn the career options available in Pharmacovigilance and what skills are expected.
  • Become aware of the regulatory requirements of PV for all major geographical regions.
  • Learn the types of activities involved in the safety assessment of drugs/devices.
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