Pharmacovigilance Quality Assurance & Compliance Auditing
A Top 10 Global Biopharmaceutical Company faced increasing regulatory scrutiny and needed to strengthen its Pharmacovigilance (PV) quality systems worldwide.
The project included 15+ global PV audits across 9 months, addressing inconsistent PV practices across affiliates, gaps in SOPs and training documentation, and risks of major findings during upcoming health authority inspections.
Vigilare executed a structured PV Quality Assurance program that included risk-based audits, CAPA implementation, harmonized SOPs, and inspection readiness workshops.