The Client

The client is a United States-based science-led, patient-centered biopharmaceutical company focused on discovering, developing and commercializing medicine for patients with rare disease. 

Project Scope

The client requested that ProductLife Group (PLG) take over the project management and oversight of local pharmacovigilance (PV) activities in 21 countries from the client’s previous third-party provider. Requested support included a local qualified person for pharmacovigilance (LQPPV)/local contact person for pharmacovigilance (LCPPV) activities with full product oversight and additional support, a deputy QPPV, and local literature surveillance. 

Challenges

Because the client wanted to quickly and efficiently terminate existing contracts with its previous third-party provider, seamless transition of local oversight had to be accomplished, ensured, and maintained for compliance purposes, and project and team scale-up had to be managed quickly and efficiently to meet the client’s tight timelines. 

Risk factors and requirements

PLG’s well-established local PV providers were selected because they could offer competency, efficiency, and compliance in meeting the client’s emerging needs. 

 Case Study on how PLG steps In to Take On Local PV Role for US BioPharma Client for 21 Countries in 2016 that Developed into 37 Countries in Total by 2021. 

PLG Success Factors

Since the client first turned to PLG for local PV support in 2016, the relationship between the two has expanded to include support in another 16 countries in addition to 3 new products, which led to a consistent annual contract renewal based on client’s satisfaction and request, in which local literature surveillance has been requested as the company awaits product authorization. The client is also liaising with PLG for QPPV support in the Middle East.

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Case Study: Worldwide Local Pharmacovigilance support