CSP – Pharmacovigilance

300 300 logo
WhatsApp Image 2023-02-13 at 21.39.09
Last Update September 12, 2023
4.17 /5
199 already enrolled

About This Course

Course Objective

Extensive knowledge with detailed understanding of basics imparted to equip you to work at any global Clinical research organizations (CROs) or Pharmaceutical companies or Pharmacovigilance service providers.

Understand the topic to gain the skills, knowledge and competencies of a right candidate for the
Pharmacovigilance sector.

Overview of practical aspects of Pharmacovigilance activities as per the global standards like safety reporting, medical evaluation, casualty assessment, expectedness assessment, case processing, narrative writing, MedDRA etc. to make a student industry ready.

Learn to appear the interview with confidence and grab the best deserved job based on your skillset.

Why attend this training?
Pharmacovigilance & Clinical research is rapidly growing industry globally with growth rate of more than 40% per year. Being a particular specialty, this sector requires trained and skilled workforce, with basic understanding of Clinical Research, Clinical Data Management & pharmacovigilance. This is why, over any unskilled candidates, they prefer them who already understands the basics of safety reporting & it’s impact. In a typical pharmacovigilance department or specialized pharmacovigilance company, there are several positions. Pharmacovigilance offers excellent growth prospects. Here are some of the positions a fresher can get selected for- Drug Safety Associate; Drug Safety Scientist; Aggregate Report Scientist; Pharmacovigilance associate; Safety report specialist etc.

What are the benefits of this course after college?
At the end of this course you’ll gain comprehensive knowledge to the pharmacovigilance basics, clinical research processes, drug development process, regulatory affairs, essential documentation, roles and responsibilities, ethics, monitoring, conduct and management of trials, extensive training on Pharmacovigilance (PV) related issues. In other words, the students taking this course will completely industry ready as freshers.

Trainer’s Profiles:

Trainer is an M. Pharm degree holder in Medicinal Chemistry. She has more than 5 years of working experience in core pharmacovigilance industries like Cognizant, Wipro & Bioclinica (Currently known as Clario). She has performed roles of case processor, quality reviewer, trainer, training lead and team lead, which have led her to gain exclusive knowledge & skills in this field handling practical scenarios.

Learning Objectives

This course benefits all the final year, recent graduate and working professionals.

Target Audience

  • Final year students, interns and 2022 graduates.
  • Working professionals are eligible only on the Management Approval.


16 Lessons20h

Session 1: Introduction to Pharmacovigilance, history, background

Pharmacovigilance – Introduction to the Course2:03
Part 1: Introduction to Drug Discovery, Clinical Trials and Pharmacovigilance17:16
Part 2: Understanding History, Background & Significance of Pharmacovigilance10:09

Session 2: Significance of Pharmacovigilance, workflow of PV

Session 3: Aggregate safety reporting

Session 4: Signal Detection & Risk Management – Part1

Session 4: Signal Detection & Risk Management – Part2

Session 5: Adverse drug reaction

Session 6: Different types of reports and ICSRs

Session 7: Case processing overview (ICSR) Database basics

Session 8: Understanding MedDRA and other drug dictionaries

Session 9: Narrative writing

Session 10: Introduction to Pharma, Biotech & Medical Device Industries Bonus Topic Pharmacovigilance Job Interview

PV – Certification Exam

Additional Study Material

Student Feedback

6 Ratings

Reviews (6)

it was good

was helpful and handy to understand PV terms


Educative and engaging.



Write a review

Copy of Copy of Untitled (1104 × 736 px) (1400 × 860 px)(1)


All Levels
Duration 20 hours
16 lectures

Material Includes

  • All materials are provided in the program.

Want to receive push notifications for all major on-site activities?