Your responsibilities include, but not limited to:
- Enhance Patient Safety Japan associates’ medical knowledge throuth organized educational programme.
- Review ICSRs, periodic reports, J-RMP, draft changed labeling, PMS plan, re-exmination dossier, etc.
- Provide medical advice for any aspects relating Patient Safety.
- Attending SEC as core member.
- Support PVO-J associates to obtain necessary information on reported safety case for assessment.
- Ensure adequate reporting of adverse events / technical complaint / compliance issue in accordance with company procedures.
- 100% timely delivery of all training requirements including compliance.
What you’ll bring to the role:
- Provide comments on pharmacovigilance, re-examination and post marketing surveillance related materials from medical point of view