Author: Dr. Chitra Lele, Sciformix Corporation
The drug safety landscape continues to evolve with the dynamic pharmaceutical marketplace. Increased regulatory requirements, importance of emerging markets, global partnerships across multiple stakeholders and shifting mix of small and large molecules are important factors which mandate a truly global Pharmacovigilance (PV) system. Global resourcing is a key element of this system.
Outsourcing in the pharmaceutical market has grown vastly over the last 10 years (1), with the PV market estimated to reach $5b in 2019, at a CAGR of 12.9% from 2013 to 2019 (2). It has become almost standard practice among multinational companies to develop global sourcing programs that utilize specific geographic and domain expertise, harmonize and standardize processes, integrate new technologies and find ways to manage volume fluctuations to enhance efficiencies and drive cost reductions. The success of these programs depends heavily on its impact on resource optimization, ability to improve compliance with respect to safety and risk management and enabling proactive PV.