About
The Certification in Pharmacovigilance Essentials is a 6-hour self-paced course that trains you in the fundamentals of drug safety and real-world pharmacovigilance (PV) operations. Perfect for freshers and professionals in pharma, life sciences, and clinical research, this course prepares you to work confidently in global regulatory environments. You’ll learn how to: • Understand the core principles of drug safety and pharmacovigilance • Identify and classify ADRs, AEs, SAEs, SUSARs, and use MedDRA • Process Individual Case Safety Reports (ICSRs) and safety data • Handle spontaneous reports, literature cases, and follow-ups • Work with global regulations (US FDA, EMA, CDSCO, WHO) and GVP standards Who is this for? Graduates in pharmacy, life sciences, nursing, MBBS, or anyone looking to build a career in pharmacovigilance or drug safety. What’s included? • ICSR templates, AE trackers, and safety narrative samples • Regulatory timeline cheat-sheets (FDA vs EMA vs CDSCO) • MedDRA hierarchy and GVP module visual guide