This program covers global regulatory guidelines, case processing, signal detection, risk management, and aggregate reporting, equipping learners with the necessary skills to work in pharmaceutical companies, contract research organizations (CROs), and regulatory agencies. Learning Objectives: ✔ Understand the principles of pharmacovigilance and its importance in public health. ✔ Identify, assess, and report adverse drug reactions (ADRs). ✔ Process Individual Case Safety Reports (ICSRs) and perform narrative writing. ✔ Analyze safety signals and prepare risk management plans (RMPs). ✔ Develop Periodic Safety Update Reports (PSURs) and other aggregate reports. ✔ Gain hands-on experience with pharmacovigilance databases and MedDRA coding. ✔ Comprehend global pharmacovigilance regulations (FDA, EMA, ICH, WHO). ✔ Understand career opportunities in pharmacovigilance and drug safety. Course Curriculum: ✅ Introduction to Pharmacovigilance & Drug Safety ✅ Adverse Drug Reactions (ADRs) & Causality Assessment ✅ ICH Guidelines (E2A, E2B, E2C, E2D, E2E, E2F)) ✅ Individual Case Safety Reports (ICSRs) – Case Processing & Narrative Writing ✅ MedDRA Coding & Labeling ✅ Signal Detection, Risk Management, & Risk Minimization Strategies ✅ Periodic Safety Update Reports (PSURs) & Aggregate Reporting ✅ Safety communications ✅ Safety Narrative Writing for Drug Safety & Literature Review ✅ Career Opportunities & Industry Insights Mode of Delivery: • Online & Classroom Training Available • Live Instructor-Led Sessions & Self-Paced Learning • Assignments, Case Studies & Interactive Discussions