Senior PMS Lead
Core
Provide strategic and operational leadership for post-marketing surveillance (PMS) activities, including study planning, execution oversight, and regulatory submissions for assigned products in Japan.
Role type
Senior management lead for post-marketing surveillance (PMS)
Builds
PMS strategies, study protocols, regulatory dossiers, and inspection-ready documentation
Domain
Pharmaceutical regulatory affairs (Japan)
Required skills
PMS/GPSP strategy, Japanese pharmaceutical regulations, study design, data management, statistical analysis, vendor governance, CAPA management, inspection readiness
Preferred skills
Epidemiology, biostatistics, real-world evidence, team leadership, CRO management
Technologies
EDC, CRF, SAP, J-PSUR, RMP
Responsibilities
Lead PMS strategy and study planning; author and review regulatory reports and submissions; oversee data management and statistical analysis; manage vendor governance and outsourcing; lead CAPA and continuous improvement; support inspection readiness and audits; collaborate cross-functionally with PV, RA, Medical, and Global teams
Seniority
Senior, management level