Associate Director, Global CST, Pharmacovigilance PSMF and Business Process Management
Core
Manage the Pharmacovigilance System Master File (PSMF) life-cycle and optimize global business processes for pharmacovigilance compliance.
Role type
Associate Director, Global Pharmacovigilance PSMF and Business Process Management
Builds
Global PSMF system, procedural documents, and optimized PV business processes
Domain
Biopharmaceuticals / Pharmacovigilance / Regulatory Compliance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
PSMF life-cycle management, business process optimization, regulatory compliance (FDA/EU GVP), KPI/KRI monitoring, process mapping methodologies (Value Stream Mapping, SIPOC), quality systems management, case processing oversight
Preferred skills
Experience with Veeva SafetyDocs, industry forum representation, data analysis for PV metrics
Technologies
Veeva SafetyDocs
Responsibilities
Direct end-to-end authoring, review, and maintenance of the global PSMF; coordinate with cross-functional leaders for data inputs; ensure PSMF readiness for health authority inspections; monitor global GVP updates and drive system changes; compile KPIs and PSMF logbooks for executive leadership; represent the company on industry PSMF forums; facilitate development of procedural documents; optimize business processes using mapping and re-engineering; monitor process health via KPIs and KRIs; track controlled procedural document life-cycles; support CSPV inspection readiness; review and report on ICSR and aggregate report quality metrics
Seniority
Senior, hands-on IC with strategic oversight
