Pfizer: Managing Drug Safety Across Global Partnerships
We’ve been able to centralize the tracking of exchange of adverse events, aggregate reports, and safety signals with our partners in our global group. That was only made possible by having the efficiencies and the automation that the system brought.
- Managing PVAs for 5,800 products across 500 partners
- Reduced reporting efforts from 5 days to half-day
- Eliminated manual tracking of periodic reviews
- Improved ability to demonstrate compliance and support audits
The Business Issue
Like all pharmaceutical companies, Pfizer is responsible for constant and comprehensive oversight for the safety of its products. This effort-intensive responsibility becomes even more complex and challenging when it comes to global partners.
From a practical perspective, Pfizer needed to manually manage pharmacovigilance agreements (PVAs) with its hundreds of global partners and actively track all PV activities defined by those PVAs for thousands of products worldwide. Strict regulatory oversight from health authorities and frequent reporting and audit requirements means that Pfizer also must be able to provide transparency and complete auditability.
Pfizer leveraged Pega’s industry-leading business process management and dynamic case management capabilities, along with Pega’s Pharmacovigilance application to deliver its Pharmacovigilance Exchange (PVX) solution in less than four months. Pfizer’s rapid deployment was facilitated not only by Pega’s Direct Capture of Objectives tool, but also by Pega’s patented Situational Layer Cake, which enabled the reuse of many of Pfizer’s existing components from other Pega solutions throughout Pfizer, reducing development efforts by an estimated 30%.
The PVX application has reduced or eliminated a significant amount of manual work for Pfizer. It starts with the creation or import of a PVA. The lifecycle of each PVA is managed within Pega, including creation, review, approval, and updates. PVA milestones are automatically tracked with notifications and alerts for key dates. This alone improves transparency and compliance, but it’s actually the second component of the application that delivers the most innovation and value.
- Life Sciences