Advanced Diploma in Next-Gen Pharmacovigilance

Detailed Syllabus & Weekly Breakdown

Module 1: PV Operations & Medical Coding (Weeks 1–6)

Focus: Mastering the "Bread and Butter" of PV.

• Week 1: Pharmacovigilance evolution; the 2025 landscape; patient safety ethics
• Week 2: ICSR Lifecycle: Intake, Triage, and Data Entry
• Week 3: Narrative Writing: Clinical storytelling and causality assessment (Naranjo/WHO)
• Week 4: MedDRA & WHODrug: Advanced coding and SMQ
• Week 5: Software Lab: Hands-on with Safety Databases (Argus/ArisG)
• Week 6: Assessment: Case Processing Practical and Coding Quiz

Module 2: Global Regulatory Frameworks & Literature (Weeks 7–12)

Focus: Navigating the complex legal landscape.

• Week 7: EU GVP Modules (I–XVI) and QPPV role
• Week 8: US FDA (21 CFR 312/314) and CDSCO
• Week 9: Literature Monitoring: Local vs Global
• Week 10: Special Cases: Pregnancy, Overdose, Off-label use, Lack of Efficacy
• Week 11: Quality Management: SOPs, Deviations, Audit readiness
• Week 12: Assessment: Regulatory Strategy Memo

Module 3: Signal, Risk & Aggregate Reports (Weeks 13–18)

Focus: Strategic Safety Analysis.

• Week 13: Signal Detection (PRR, ROR, MGPS)
• Week 14: PBRER & DSUR
• Week 15: Safety Report Writing
• Week 16: Risk Management Plans (RMP, REMS)
• Week 17: Safety Estimands
• Week 18: Signal Evaluation Workshop

Module 4: Agentic AI & Safety Leadership (Weeks 19–24)

Focus: Future of PV.

• Week 19: Agentic AI
• Week 20: GenAI for Medical Writing
• Week 21: Crisis Management
• Week 22: Capstone Part A
• Week 23: Capstone Part B
• Week 24: Final Viva

Learning Outcomes

• Process complex ICSRs with high accuracy
• Navigate EudraVigilance & FDA FAERS
• Evaluate safety signals
• Integrate AI tools in PV

Assessment Weightage