Program Structure

Module 1: Introduction to Pharmacovigilance

• What pharmacovigilance is and why it matters across drug development and post-marketing.
• Key terms: AE, ADR, SAE, SUSAR, signal, risk management (conceptual clarity).
• Roles in PV: case processors, QC, medical reviewers, safety physicians, QPPV (overview).
• PV lifecycle: detection → assessment → reporting → risk minimization.

Module 2: Sources of Safety Data

• Spontaneous reports, literature cases, clinical trials, and post-marketing sources.
• Call centers, emails, social media and digital channels (overview of intake reality).
• Minimum criteria for a valid case (conceptual workflow).
• Data quality basics: completeness, follow-up, and duplication handling.

Module 3: Individual Case Safety Reports (ICSR) & Case Processing

• Case intake and triage: seriousness, expectedness, and urgency (overview).
• Case narrative writing: clarity, chronology, and medical relevance.
• Data entry concepts: patient info, product, event, outcome, concomitants.
• Quality checks: common errors and how to avoid them.

Module 4: Seriousness, Expectedness & Causality (Practical Understanding)

• Seriousness criteria: hospitalization, disability, death, congenital anomaly, etc.
• Expectedness concept: label vs unlabelled events (overview).
• Causality assessment basics: temporal association, dechallenge/rechallenge, alternatives.
• Special situations: pregnancy, overdose, medication error, abuse/misuse (overview).

Module 5: Medical Coding Basics (MedDRA Thinking)

• Why coding exists: consistency, analytics, and regulatory reporting.
• MedDRA structure overview: LLT/PT/HLT/HLGT/SOC.
• Choosing the right term: specificity, synonyms, and avoiding overcoding.
• Common coding pitfalls and QC mindset.

Module 6: Safety Reporting & Compliance Workflows

• Expedited reporting concept: how urgent cases are managed.
• Reporting destinations overview: health authorities, sponsors, partners.
• Timelines mindset: why day counts matter and how teams track them.
• Documentation discipline: audit trails, versioning, and completeness.

Module 7: Signal Detection & Risk Management (Overview)

• What a signal is: patterns, disproportionality concept, and clinical judgment.
• Signal validation and escalation: when a signal becomes a safety concern.
• Risk management plans (RMP) concept: how risks are minimized.
• Safety communication: labeling updates and risk minimization measures (overview).

Module 8: Aggregate Reports & Safety Documentation (Overview)

• Why aggregate reports exist: periodic safety review logic.
• PSUR/PBRER concept and what they typically contain (high-level).
• Company core safety information (CCSI) concept.
• Inspection readiness: what auditors commonly expect to see.

Module 9: PV Quality System & SOP Mindset

• PV quality system: SOPs, training, deviations, and CAPA (overview).
• Data privacy basics: handling sensitive patient information responsibly.
• Vendor and partner management concepts in PV operations.
• Career mapping: PV roles and progression pathways.

Final Project

• Complete a PV Case Processing Mini-Portfolio.
• Deliverables: 2–3 sample cases (simulated), narratives, seriousness/causality notes, coding choices, and a compliance checklist.
• Optional add-on: create a simple signal summary from a small case set (guided template).