Program Structure

Module 1: Pharmacovigilance Foundations

• Why PV matters: safety, benefit-risk, compliance.
• PV across phases: trials to post-marketing.
• Key terms: AE, ADR, SAE, SUSAR (intro).
• PV systems: spontaneous reports, registries, literature (overview).

Module 2: Safety Data and Case Intake

• Minimum case criteria and data quality.
• Source types: patients, HCPs, partners, digital.
• Triage: seriousness, expectedness, priority.
• Follow-up questions and documentation.

Module 3: Case Processing Workflow

• Case forms and core fields.
• Narratives: structure and clarity.
• Duplicate detection and reconciliation.
• QC checks and audit readiness.

Module 4: Coding Concepts (MedDRA)

• MedDRA hierarchy and term selection (intro).
• Good coding practice and common errors.
• Product coding concepts and concomitant meds.
• Medical review checkpoints (overview).

Module 5: Causality and Benefit-Risk Thinking

• Causality concepts: temporal association, dechallenge/rechallenge.
• Confounders: disease, interactions, comorbidities.
• Expectedness and labeling concepts.
• Simple benefit-risk framing for safety reviews.

Module 6: Signal Detection and Evaluation

• Signals vs events: definitions and workflow.
• Disproportionality concepts (PRR/ROR overview).
• Trend review: time, geography, batch, population.
• Signal evaluation steps and documentation.

Module 7: Risk Management and Safety Actions

• Risk Management Plan (RMP) structure (overview).
• Risk minimization: education, monitoring, restrictions (intro).
• Safety communications and labeling updates (overview).
• CAPA concepts and safety governance.

Module 8: Safety Reporting and Compliance

• Expedited reporting basics (overview).
• Periodic reports: PSUR/PBRER concepts.
• Line listings and aggregate summaries.
• Inspection readiness and documentation basics.

Final Project

• Process 1–2 sample safety cases (intake → narrative → coding).
• Create a mini signal summary and risk note.
• Submit: case pack + short report.