Pharmacovigilance & Drug Safety Management

Module 1: Introduction to Pharmacovigilance

• Definition & Importance of Pharmacovigilance
• History & Evolution of Drug Safety Monitoring
• Key Regulatory Authorities (FDA, EMA, CDSCO)

Module 2: Adverse Drug Reactions (ADR) & Signal Detection

• Types & Classification of ADRs
• Causality Assessment Methods
• Signal Detection Techniques

Module 3: Regulatory Requirements & Reporting Systems

• International Regulations (ICH, WHO, GVP)
• Individual Case Safety Reports (ICSR) & Periodic Safety Update Reports (PSUR)
• Electronic Reporting Systems (EudraVigilance, MedWatch)

Module 4: Risk Management & Compliance

• Risk Minimization Strategies
• Post-Marketing Surveillance (PMS)
• Pharmacovigilance Inspections & Audits

Module 5: Data Management & Safety Databases

• Pharmacovigilance Databases (ARGUS, ARISg)
• Case Processing & Data Entry
• Ensuring Data Integrity & Confidentiality

Module 6: Career Opportunities & Future Trends

• Roles & Responsibilities in Drug Safety
• Emerging Trends in Pharmacovigilance
• Certification & Career Pathways