Artificial Intelligence in Pharmacovigilance

From use cases to inspection-ready governance, validation and human oversight

Course overview

This is not a general AI awareness course. It focuses on how AI changes regulated PV work in practice: process design, human oversight, validation, vendor control, data integrity, audit trails, accountability and inspection readiness.

Artificial intelligence will not remove accountability from pharmacovigilance. It changes where accountability must be designed, documented and demonstrated.

This course helps participants understand how AI can support PV work while maintaining regulatory compliance, patient safety, data integrity and inspection readiness.

The course focuses on practical, inspection-ready AI adoption in pharmacovigilance. It should not present AI as a generic technology trend, but as a controlled change to regulated PV work: data flows, decision-making, oversight, validation, governance, vendors and accountability.

Training Leader: Reinhold Schilling