Leap of fAIth

Published 8 September 2026

Author(s): Jason Bryant

What does CIOMS XIV mean for operationalised AI use in pharmacovigilance?

With AI now embedded in day-to-day pharmacovigilance, most drug safety operations have moved beyond considerations about whether a system can be validated for its intended use.

The bigger test comes further down the line, once inputs vary and models have been updated, at which point organisations still need to show the system remains safe and properly governed.

Here, ArisGlobal’s Jason Bryant reflects on the implications for pharma organisations now operationalising AI use in a PV context, drawing on a recent podcast discussion with Denny Lorenz, an active member of the CIOMS XIV working group.