AI in pharmacovigilance: a governance-first blueprint for ICSR intake, signal detection, and MedDRA coding

AI belongs in pharmacovigilance as governed, scoped workflows — ICSR intake, MedDRA coding assistance, literature triage, and signal-detection support — with qualified human reviewers, QPPV oversight, GAMP 5 second edition-aligned validation, and a complete audit trail behind every regulated decision.

• Why PV is the highest-stakes AI use case in life sciences
• Four PV workflows where AI earns its place: intake, MedDRA, literature, signals
• Five governance surfaces: scoped task, retrieval, tool boundaries, approval, audit trail
• Validation proportionate to GAMP 5 second edition and EU AI Act Article 14 oversight
• A ninety-day pilot model from scoping to assisted live operation