Setting up a Global PV System
A company needed to rapidly establish a fully compliant global pharmacovigilance (PV) system, including UK/EU QPPV coverage, to meet regulatory requirements by a fixed deadline. With safety data and license responsibilities held by a licensing partner, the transition posed significant regulatory, operational, and stakeholder coordination risks.
ProPharma partnered with the company to design and execute a comprehensive PV transition and implementation plan. Within four weeks, ProPharma mobilized full-scope PV services — including UK/EU QPPV support, global safety database setup, aggregate reporting, signal detection, and literature surveillance. The team also negotiated a Safety Data Exchange Agreement and led the secure transfer and migration of safety data despite complex partner dynamics.
The result was a fully operational, audit-ready global PV system delivered on time, with no critical audit findings. Over the next two years, the partnership expanded to support launches in 12 countries and unlicensed supply across more than 40 countries worldwide.
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