Manage 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
Want more jobs like this?
Get jobs in Kamimaruko, Japan delivered to your inbox every week.
