☑English language required
☑Japanese language required
Japan Safety Leader
Responsible for managing following major tasks, and advise other colleagues based on rich Pharmacovigilance (PHV) expertise as Senior Staff
- Monitor the benefit risk profile of assigned portfolio in an ongoing fashion by organizing PVPT and providing evaluation to Safety review Meeting (SRM) and by chairing the local Safety Management Team (SMT).
- Ensure effective and timely delivery of safety-related documents, such as PHV part of NDA dossier, replies to Health Authority (HA) inquiries, RMP, Proper Use Guide, EPPV report, J-PSUR and emergency letter.
- Drive strategic preparation for the NDA filing/approval/launch of products in charge by fostering team spirits among PVPT and local SMT
- Communicate in a timely, transparent and proactive manner with GPV functions about local RMP/Risk Monitoring and Risk Minimization
- Activities including update of Global Tracking Too
- At least 5 years of experience in a Pharmacovigilance role
- Good knowledge of pharmacovigilance relevant regulations
- High quality writing skills in safety relevant documents
- Good communication skill with counter parts such as relevant department, regulatory agency and global relevant team
- Building partnerships and working collaboratively with others to reach common goal
- Excellent problem solving skills in complex, high quantity and sometimes contradictory information.
- English Language level: Business level
- Japanese Language level: Native Level (Equivalent to JLPT N1)
- Work permission in Japan required
9〜13 million JPY
※Experiences and skills will be considered
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Further details about the company and position will be notified at a later date.
Seniority Level: Mid-Senior level
Job Function: Health Care Provider, Quality Assurance