Definition

A medically qualified professional who provides clinical expertise in evaluating adverse events, assessing causality, and making safety determinations.

Example

The PV physician reviews complex cases involving unexpected serious events, assesses the medical plausibility of reported relationships, and provides input for signal evaluation.

Regulatory source

EU GVP Module I

Common mistakes

Not involving PV physicians early enough in case processing, or having insufficient physician resources for case volume.

Inspector question

How many PV physicians support your operations? What criteria trigger physician review?

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