Case Study: Pfizer achieves centralized global pharmacovigilance, faster reporting and improved compliance with Pegasystems

Pfizer Managing Drug Safety Across Global Partnerships

Pfizer faced the challenge of ensuring continuous, auditable safety oversight for thousands of medicines across hundreds of global partners. Manually managing pharmacovigilance agreements (PVAs) and tracking PV activities for 5,800 products with 500 partners created heavy reporting burdens, manual periodic-review tracking, and a need for transparent, audit-ready processes under strict regulatory scrutiny.

Pfizer implemented Pega’s Pharmacovigilance Exchange (PVX) in under four months, leveraging Pega’s Direct Capture of Objectives and Situational Layer Cake to reuse components and cut development effort by about 30%. PVAs and their lifecycles are now managed in Pega with automatic milestone tracking, notifications, and alerts—eliminating manual tracking, reducing reporting time from five days to a half-day, and improving transparency and the ability to demonstrate compliance during audits.

Pfizer

Jeffrey Hanson

Senior Information Analyst