Pharmacovigilance (PV) is the science and activities relating to the detection, assessment, understanding, and prevention of adverse effects or any other drug-related problems. It is the global safeguard that ensures medicines remain safe for patients long after they hit the market.
Every approved drug continues to be monitored throughout its entire lifecycle. PV professionals are the critical link between patient safety reports, regulatory agencies, and pharmaceutical companies — ensuring that risks are identified early and action is taken swiftly. The stakes could not be higher: lives depend on this work.
The global pharmacovigilance market is projected to reach over $12 billion by 2030, driven by tightening regulatory requirements, increasing drug approvals, and expanding access to medicines in emerging markets. India, with its massive generic pharma base, is a major hub for PV operations.
CodEvo's Pharmacovigilance Training Program is designed and delivered by working PV professionals with direct experience in drug safety databases, ICSR processing, signal detection, and regulatory submissions. You will graduate job-ready — not just certificate-ready.
A structured, mentor-guided path that takes you from foundational drug safety knowledge to a placed PV professional.
Every module is crafted and reviewed by practising pharmacovigilance professionals from the pharmaceutical and CRO industry.
You will train on the exact platforms used daily inside CROs and pharmaceutical drug safety departments around the world.
Global drug safety is governed by a complex web of guidelines. Our program ensures you can navigate every major framework with confidence.
US federal regulations governing post-marketing adverse event reporting, IND safety reports, and NDA/BLA periodic submissions. Covers MedWatch form 3500A, FAERS submissions, and REMS (Risk Evaluation and Mitigation Strategies) requirements for high-risk products.
The complete ICH safety guideline series — covering expedited reporting (E2A), electronic ICSR format (E2B), periodic reporting (E2C), post-approval data management (E2D), PV planning (E2E), and development safety updates (E2F). The backbone of global PV practice.
The European Good Pharmacovigilance Practice (GVP) guidelines consist of 16 modules covering PSMF, signal management, PSUR, RMP, and post-authorisation safety studies. Compulsory knowledge for anyone working on EU-marketed products.
The Central Drugs Standard Control Organisation (CDSCO) and Pharmacovigilance Programme of India (PvPI) framework, including Schedule Y reporting requirements, AMCs (Adverse Drug Monitoring Centres), and India-specific ICSR obligations for MAHs.
The World Health Organisation's Uppsala Monitoring Centre (WHO-UMC) causality assessment system, VIGIFLOW reporting, and the VigiBase global ICSR repository. Fundamental to understanding international pharmacovigilance in resource-limited settings.
The Pharmacovigilance System Master File is the cornerstone EU documentation requirement for MAHs. Covers SOP writing for PV processes, audit and inspection readiness, CAPA management, and quality oversight metrics for a compliant PV system.
Our graduates go on to work across the entire drug safety ecosystem — from boutique PV service providers to the largest global pharmaceutical companies.
India is home to over 3,000 pharmaceutical manufacturers and accounts for 20% of global generic drug exports. With CDSCO tightening PV regulations and global pharma companies expanding their India operations, trained PV professionals are in urgent demand across Hyderabad, Mumbai, Bengaluru, and Chennai.
Explore Career PathsThis program is open to anyone with a life science background who wants to build a meaningful career in drug safety and patient protection.
What makes our Pharmacovigilance program stand apart from every other PV course available in India.
Enroll in CodEvo's Pharmacovigilance program and step into one of the most impactful careers in medicine — protecting patients, shaping regulations, and driving global drug safety.