Associate Director, Global Patient Safety

SUMMARY/POSITION OBJECTIVE:
The Associate Director shall report to GPS Director in Japan and performs as deputy Anseki (Safety Control Manager) and Choseki (Post-Marketing Surveillance Manager) as needed. Responsibilities include the management and oversight of external service providers providing services related to GxPs operation, the establishment of the J-RMP, and who contribute to the J-NDA and annual report.

JOB DUTIES:
 - Serve as the primary backup for the Head of Japan PV including but not limited to acting as the Deputy Anseki when required and supporting the Choseki as needed. 
 - Engage in activities related to the safety of both investigational and marketed products. 
 - Manage and oversee CRO performance related to all outsourced safety operations. 
 - Establish and maintain J-RMP operations including the risk minimization plan.
 - Contribute to the safety sections of the J-NDA and support the resolution of any PMDA inquiries.
 ...