- Tokyo, Tokyo, Japan
- On-site
- Full-time · Associate
- 3+ years
Acts as lead for the execution of local (in country) pharmacovigilance activities aligned with the global pharmacovigilance function, implementing safety measures for pre- and post-marketing Mundi products based on local regulations.
Responsibilities
- Management and oversight of local vendor for operational activities including case management, local literature monitoring, and PV training
- Resolving issues inquiries about ICSR from PMDA
- Monitoring compliance and performance metrics and quality/timely delivery of safety outputs by the vendor
- Preparing periodic safety reports with PMS responsible person and Department head
- Collaborating with Central Safety Systems team in maintaining a single global safety database (Argus J module)
Requirements
- Bachelor’s degree of faculty of science and technology
- Master’s degree of faculty of science and technology