International pharmacovigilance: A strategic global model for compliance and patient safety

The globalization of pharmaceutical development and commercialization has significantly increased the complexity of Pharmacovigilance (PV) operations. Marketing Authorization Holders (MAHs), ranging from large multi-national pharmaceutical organizations to emerging biotech companies, face growing challenges in maintaining compliance with diverse and evolving global PV regulations while ensuring patient safety. International Pharmacovigilance (IPV) requires not only centralized oversight but also local expertise, country-specific regulatory knowledge, qualified local personnel and robust operational infrastructure. As regulatory expectations continue to expand globally, outsourcing to an integrated PV service provider offering end-to-end global and local PV capabilities has become a strategic necessity rather than an operational option. This white paper explores the challenges faced by MAHs and presents a comprehensive  solution through a globally integrated PV service model.