Optimizing Local Affiliate PV Operations

A mid-sized biopharmaceutical company, with operations spanning the Americas, Europe, Asia-Pacific, Africa, and the Middle East, faced significant challenges in managing local pharmacovigilance (PV) processes across its global network. Tight timelines, licensing limitations in its legacy PV system, and a need for improved cross-functional communication required a complete overhaul.

After evaluating multiple vendors, the company selected PharmaLex to design and implement a new model for processing Individual Case Safety Reports (ICSRs). PharmaLex deployed an 81-strong team of local PV experts, including experienced Regional Leads, to meet capacity needs. They also developed a centralized Oracle Argus LAM Hub for global ICSR processing, enhancing efficiency and compliance. By establishing a standardized process and a collaborative workspace for training and performance tracking, PharmaLex helped the company improve oversight, accuracy, and communication across 94 countries, driving significant improvements in quality, compliance, and cost control.

Access the full case study to see how this streamlined solution helped the company improve efficiency, compliance, and cross-functional communication across 94 countries.