White Paper
From Automation to Decision Intelligence
The Next Operating Model for Pharmacovigilance
Sep 21, 2026

Faced with the challenge of maintaining safety while monitoring evergrowing volumes of data (often with shrinking teams), pharmacovigilance (PV) teams have made significant progress in recent years in using AI for workflow automation.

That kind of AI use is necessary, but not sufficient for the challenges these teams face today. In order to keep pace with the evolution of the space, PV teams will need to deploy AI to also support signal detection and risk management.

To do this, while maintaining patient safety, will require organisational readiness around data, governance, and trust, as well as a nuanced understanding of when, how, and why human-in-the-loop is necessary.