Pharmacovigilance & Drug Safety
Pharmacovigilance (PV) ensures post-marketing drug safety worldwide. Master Individual Case Safety Report (ICSR) triaging, MedDRA medical coding, narrative writing, causality assessment (WHO-UMC), aggregate reporting (PSUR/PBRER), and safety databases (Argus Safety).
🇮🇳 Indian Market Benchmark
Core Track Highlights
End-to-End Pharmacovigilance & ICSR Processing Pipeline
Adverse event intake, triage, MedDRA coding, narrative generation, medical review, and regulatory e-submission.
Case Intake & Triage
Validating 4 criteria: Identifiable patient, reporter, suspect drug, and adverse event.
MedDRA Coding
Mapping clinical terms to System Organ Classes (SOC) and Preferred Terms (PT).
Narrative Authoring
Writing chronological clinical summaries highlighting onset, dechallenge, and rechallenge.
Safety Submissions
Expedited 15-day reporting to US FDA (FAERS), EMA (EudraVigilance), and CDSCO.
Structured Phase-by-Phase Syllabus
Focus on build-by-doing milestones rather than passive video consumption.
Phase 1: PV Fundamentals, MedDRA & Case Triage
- Introduction to Pharmacovigilance: History (Thalidomide disaster) and regulations (ICH E2A to E2F)
- Valid ICSR criteria: Identifiable patient, identifiable reporter, suspect medicinal product, adverse event
- MedDRA hierarchy: SOC, HLGT, HLT, PT, LLT and WHO Drug dictionary mapping
Phase 2: ICSR Processing & Narrative Writing in Argus Safety
- Data entry workflow in Oracle Argus Safety: General, Patient, Product, Event, and Analysis tabs
- Medical narrative writing: Chronological structure, lab findings, dechallenge/rechallenge analysis
- Causality assessment methods (Naranjo Algorithm, WHO-UMC criteria) and Seriousness criteria
Phase 3: Aggregate Reporting, Signal Detection & Audits
- Periodic Safety Update Reports (PSUR / PBRER) and Risk Management Plans (RMP)
- Signal detection methodologies: Disproportionality analysis, PRR, and ROR metrics
- Inspection readiness for US FDA, EMA, and Pharmacovigilance Programme of India (PvPI) audits
Technical Interview Questions & Answers
Q1: What are the four mandatory minimum criteria for an Individual Case Safety Report (ICSR) to be valid?
An ICSR is valid only when all four elements exist: (1) An identifiable patient (initials, age, gender), (2) An identifiable reporter (name, contact, qualification), (3) At least one suspect drug/medicinal product, and (4) At least one adverse event or fatal outcome.
Frequently Asked Questions
What is the standard expedited reporting timeline for a serious unexpected adverse drug reaction?
Fatal or life-threatening serious unexpected suspected adverse reactions must be reported to health authorities (FDA/EMA) within 7 calendar days; all other serious unexpected cases within 15 calendar days.
Target Job Roles
Drug Safety Associate / PV Scientist
Demand: Very HighSenior Drug Safety Officer / Medical Reviewer
Demand: HighRelated Career Tracks
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