Associate Director, Global CST, Pharmacovigilance PSMF and Business Process Management

Role: Senior Pharmacovigilance (PV) System Specialist responsible for PSMF lifecycle management, process optimization, and PV compliance. Responsibilities: authoring, reviewing, and maintaining the global Pharmacovigilance System Master File (PSMF) using Veeva SafetyDocs; coordinating with cross-functional teams (Clinical Operations, Regulatory, Quality) to ensure data accuracy and audit readiness; monitoring regulatory updates to maintain compliance; developing procedural documents; applying process improvement methodologies; and tracking KPIs and KRIs to support continuous quality and process improvements. Qualifications: Bachelor's degree in healthcare or a scientific field; 10+ years in PV with at least 4 years in PV compliance and quality; extensive experience with PSMF, safety systems, and industry regulations (FDA, EU GVP, UK); strong knowledge of case processing, data quality review, and PV system performance evaluation; proven ability in process mapping, analysis, and metrics tracking; excellent communication and organizational skills. High-Value: Focus on pharmacovigilance, PV compliance, PSMF management, process optimization, and industry standards; collaboration with regulatory and quality teams; on-site or hybrid work with ongoing process improvement initiatives.