Senior Manager, Global Patient Safety
Core
Oversee Japan pharmacovigilance reporting, compliance, and safety operations for a global biopharma company.
Role type
Senior Manager, Pharmacovigilance Safety Operations
Builds
Japan-specific safety reports, regulatory submissions, and vendor-managed safety processes
Domain
Biopharmaceuticals / Pharmacovigilance / Regulatory Compliance
Deliverable
client delivery
Required skills
Pharmacovigilance operations, Post-marketing surveillance, Vendor management, Regulatory inspections, Project management, Cross-functional collaboration, Process improvement, Training development, J-RMP development, Aggregate reporting
Preferred skills
Global pharmacovigilance experience, Medical Affairs collaboration, Clinical Development collaboration
Technologies
Safety databases, Regulatory submission systems
Responsibilities
Serve as primary contact for Japan ICSR and research reports; Review vendor-prepared safety evaluations and PMDA submissions; Oversee pharmacovigilance service providers; Drive process improvements for quality and compliance; Author working instructions and deliver training; Contribute to J-RMP development; Partner with external departments on safety deliverables.
Seniority
Senior Manager, hands-on leadership
