The Hidden Risks of Outsourcing PV (and How to Mitigate Them)

Outsourcing pharmacovigilance (PV) activities can be a practical and cost-effective solution, particularly for smaller sponsors or organisations without an established internal PV function.

A specialist provider can bring expertise, established processes, systems, and additional capacity without requiring a sponsor to build an entire pharmacovigilance department.

But outsourcing does not outsource responsibility.

For sponsors, one of the biggest risks is assuming that once a PV activity has been handed to a third party, the associated compliance risk has been handed over as well.

It has not.

The sponsor remains responsible for ensuring that its pharmacovigilance system operates effectively and that regulatory obligations are met. The challenge is therefore not simply choosing a capable PV vendor, but establishing appropriate oversight of the relationship.