Beyond Automation: How Strategic LQPPV Outsourcing Future-Proofs PV Compliance In The AI Era

By Ana Pedro Jesuíno, Dominique Coleman, and Barry Mulchrone

The pharmacovigilance (PV) field is changing rapidly amidst evolving regulations, growing adverse event reporting, and an increasingly global pharmaceutical landscape. To best adapt to these shifts, Marketing Authorization Holders (MAHs) are determining how AI can be integrated into workflows to improve efficiency and reduce the burden on human experts. However, despite growing AI implementation across PV workflows, the Local Qualified Persons for PV (LQPPVs), who serve as MAH representatives in their designated countries with local health authorities, are as critical as ever.

Recent EMA guidance is emphasizing the importance of MAHs ensuring robust vendor oversight; in response, MAHs are exploring which partnerships enable streamlined vendor management. The key is opting to work with an outsourcing partner that offers a wide array of PV services, advanced technology, and ample regulatory expertise, which can help your team ease operational burdens and stay aligned with industry best practices. Download the full whitepaper to learn more about how to maintain consistent compliance as AI and PV practices evolve.