Head of PV Excellence
Tokyo, Japan Permanent Date posted Oct. 25, 2024Manage all aspects of PV Excellence Team to meet required GXP compliance as well as to contribute optimization of sanofi business. Specifically:
- Prepare, track and ensure timely submission of local periodic reports (J-PSR, ReSD, Non-serious unlisted ADR periodic report, non-serious unlisted PTC periodic report, J-DSUR, Infection periodic report).
- Prepare, track, and timely submission of GXP reports (Research report/Safety Measure Report).
- Collaborate with CSU and RA departments to plan for PSRs
- Coordination of local divestment projects and partnership
- People management
- Vendor management (multiple vendors)
REQUIREMENTS
- Advanced knowledge of local pharmacovigilance legislation
- Understanding of global requirements for pharmacovigilance by major health authorities.
- Ability to analyze, connect and interpret complex information from multiple sources and drive thoughtful risk-taking and decision-making
- Problem solving skills, excellent communication to a diverse audience
- Excellent project management skills
- Knowledge of Aggregate report tool with understanding of both business and technical requirements
- Inclusive leader with soft skills
- Knowledge of budget forecasting and management
- Native level oral and written Japanese. Advanced fluency in English
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