Pharmacovigilance is the pharmacology that deals with the detection, evaluation, and prevention of adverse drug reactions. Improving drug safety is an important challenge not only for regulators and the pharmaceutical industry, but also for prescribing physicians. This is done from the drug research and development stage to post-market drug monitoring.

It includes comprehensive theoretical and hands-on training in all aspects of pharmacovigilance, including case assessment exercises, data entry, case processing, medical coding, and narrative writing.

Who can apply for this program?

The following life science degrees are advised for applicants: Bachelor's, Master's, or PhD; MBBS; MD; B.D.S; M.D.S; B.A.M.S; B.H.M.S; B.P.T; B.Tech (Biotechnology / Pharmaceutical Science); M.Tech (Biotechnology); B. Pharm; M.Pharm; BVSC; B.Sc. (Nursing); B.Sc./M.Sc

1Course Content will be covered during the training
  • Introduction, History & Overview of Pharmacovigilance
  • Clinical Trial and Drug Development Phases
  • Roles and responsibilities in pharmacovigilance for sponsors and CROs.
  • Pharmacovigilance Life Cycle & Process
  • Introduction and obligations: EMA, CDSCO, and USFDA
  • Indian pharmacovigilance
  • Process of Clinical Development
  • segments of clinical trials at various stages
  • Unfavorable events and their sorts
  • Clinical trials and after-market medications' drug safety
  • Reporting of adverse incidents from various sources
  • Various forms of AE reporting Forms
  • Timelines for expedited reporting
  • many departments involved in pharmacovigilance
  • Functions and duties of the case receipt unit
  • Triage unit responsibilities and roles
  • For the reportable case, there are four variables.
  • severity standards for adverse events
  • Adverse event expectedness or listedness
  • Evaluation of the unfavorable event's causality
  • a description of safety databases and their various forms
  • Case quality review, medical review, and submission for narrative authoring.
  • The PSUR and its submission deadlines for the Qualified Person for Pharmacovigilance (QPPV) in the European Economic Area

Benefits of learning Pharmacovigilance at Solve Tech Training Institute

  • Our experienced professionals are instructing this course.
  • Solve Tech provides you the facility to schedule the classes according to your availability.
  • Following each session, you'll receive the course material for your own future reference.
  • You will receive an internationally recognised certification after completing the course.


Focused Training
Placement Assistance
Lab Support
Expert Trainers

Flexible Timing
Interview Prepration
Hands on Training
Affordable Course Fee