The Evolving Landscape of Pharmacovigilance

Pharmacovigilance (PV) has become a critical pillar of drug development and post-market safety in an increasingly complex regulatory and patient-centric world. Rising regulatory scrutiny, broader data sources, and greater demands for real-time safety surveillance are reshaping how PV functions operate. However, traditional PV service delivery models—largely manual, linear, and resource-heavy—are struggling to meet these evolving demands.

Across sponsors, CROs, and service providers, functional PV teams face growing operational inefficiencies, data quality issues, and scalability concerns. These challenges are magnified by the need to maintain strict compliance with global regulations such as FDA 21 CFR Part 11, EU-GVP, PMDA guidelines, and evolving frameworks for digital therapeutics and real-world evidence.