Back

What is Pharmacovigilance?

Pharmacovigilance is the science of keeping medicines safe.
It’s about making sure every drug we use helps more than it harms — protecting patients and improving healthcare every day.People in this field work behind the scenes to detect, understand, and prevent side effects, making them the true guardians of patient safety.If you care about people’s well-being and want a meaningful career in healthcare, pharmacovigilance is where it begins.

About Pharmacovigilance Professionals

  • Pharmacovigilance professionals are the people who make sure the medicines we use are safe, effective, and trustworthy.
  • They work behind the scenes to protect patients by carefully monitoring and analyzing how drugs affect people — both during clinical trials and after they reach the market.
  • Their work helps doctors, researchers, and pharmaceutical companies make better decisions that keep patients safe and improve treatments worldwide

PV Experts play a crucial role in:

  • Patient Safety and Drug Risk Assessment
  • Regulatory Compliance and Reporting
  • Improving the Quality and Safety of Medicines

     

Roles of a Pharmacovigilance Professional:
  • Collecting and processing Adverse Event (AE) and Adverse Drug Reaction (ADR) reports
  • Conducting Signal Detection and Benefit–Risk Analysis
  • Preparing and submitting Safety Reports (ICSRs, PSURs, RMPs) to global regulatory bodies
  • Supporting Risk Management and Post-Marketing Surveillance activities

Training period

Course mode – online

Course duration : 3- 6 months

Weekdays : Monday – Friday

Weekend : Saturday and Sunday

Eligibility

• B.Pharm or M.Pharm
 • MBBS or BDS
 • BSc or MSc in Life Sciences, Biotechnology, Microbiology or Nursing
 • Any graduate from a healthcare or allied science background

Why Choose CatchU Academy

Industry-Based Curriculum

Aligned with ICH-GCP and GVP standards, covering drug safety from trials to post-marketing.

Hands-On Training

Practical learning in AE case processing, ICSRs, and signal detection using real tools.

Expert Mentors

Guidance from experienced PV professionals and medical reviewers with global expertise.

Career-Focused Learning

Prepares you for roles like Drug Safety Associate and PV Scientist with job-ready skills.

 Placement Assistance

Resume support, interview prep, and job connections with top pharma and CROs.

Proven Success

Alumni placed in leading organizations, handling real-world drug safety operations.

Course Highlights

Learn from Industry Experts

Train with professionals who’ve worked in real pharmacovigilance and drug safety roles — sharing practical insights and real-world experience.

Understand How Medicines Stay Safe

Learn how side effects are tracked, analyzed, and reported — and how your role helps ensure every medicine is safe for patients.

Practice, Test, and Grow Your Skills

Get hands-on with real PV tools, work on case studies, and take mock exams to build your confidence and technical expertise.

Get Ready for Your Dream Job

Train with professionals who’ve worked in real pharmacovigilance and drug safety roles — sharing practical insights and real-world experience.

1 . Introduction to pharmacovigilance 

Learn the fundamentals of drug development, clinical trials, and PV.

Topics Covered:

  • Overview of pharmacology and clinical trial phases
    Core concepts and roles of PV
  • Common PV terms: AE, SAE, SUSAR, MedDRA
  • Understand the fundamentals of pharmacovigilance and its role in ensuring drug safety.

2 . Medical Assessment of Adverse Events

Understand how to identify, evaluate, and report adverse drug reactions.

Topics Covered:

  • Diagnosis and classification of ADRs

  • Causality, seriousness, and expectedness assessment

  • Reporting systems: CIOMS, MedWatch, E2B

 Gain skills to evaluate and report ADRs in compliance with global standards.

3 .Case Processing and Data Management

Learn how safety data is processed, analyzed, and managed using PV tools.

Topics Covered:

  • Case intake, triage, and quality systems in PV
  • Databases: Argus Safety, ArisG
  • Signal detection, risk assessment, PSUR/PBRER

Develop competence in managing safety data and performing signal detection.

4. Medical Dictionaries in Pharmacovigilance

Understand standard medical coding systems used in PV.

Topics Covered:

  • MedDRA: coding medical terms and events
  • WHODD: drug coding and ATC classification

     Apply MedDRA and WHODD for consistent case entry and regulatory reporting.

5.GVP and Regulatory Overview

Gain knowledge of global and national PV regulations and compliance.

Topics Covered:

  • FDA, EMA, MHRA, WHO guidelines
  • PvPI and Good Pharmacovigilance Practice (GVP)
  • SOPs, audits, and regulatory inspections

Gain a clear understanding of regulatory compliance and global PV frameworks.

6.Hands-On Training and Case Study

Apply theoretical knowledge through real-world case handling.

Topics Covered:

  • Case entry and narrative writing in Argus
  • ADR form filling: CIOMS, MedWatch

     

 Acquire hands-on experience with real PV workflows and documentation.

7.Career Guidance and Interview Preparation

Prepare for your professional career in PV.

Topics Covered:

  • PV job roles and workflow overview
  • Resume support and mock interviews

     Gain the skills and confidence to begin a successful career in pharmacovigil

Frequently Asked Questions

Pharmacovigilance ensures that medicines are safe and effective by continuously monitoring and evaluating their adverse effects

Graduates in life sciences, pharmacy, nursing, biotechnology, are eligible to apply.

You can work as a Drug Safety Associate, Pharmacovigilance Officer, Case Processor, or Safety Data Analyst in pharma and health care industries.

Yes, Catchu Academy offers placement assistance with guidance, resume building, and interview preparation for top pharmaceutical industries, CRC and CRO companies.

Catchu Academy provides expert mentorship, interview training, and placement assistance with reputed companies in the clinical research industry.

Copyright ©2022 CatchU Academy. All rights reserved. Designed & Develop by NEXARCIT.