|職名||Manager, Risk Management|
|勤務地||Japan - Tokyo|
• Authorship of aggregate safety reports (e.g., J-PSR, UNADR, J-DSUR) with minimum supervision.
• Authorship of J-Risk Management Plan (J-RMP) for J-NDA and post-market updates (including associated documents, e.g. additional pharmacovigilance plan and risk minimization tools) with minimum supervision.
• Authorship of responses to regulatory agency / external stakeholders regarding simple safety enquiries (Responses to query; RtQ).
• Authorship of Early Post-marketing Phase Vigilance (EPPV) protocol with general condition, and authorship of EPPV interim and final reports with minimum supervision.
• Authorship of J-GVP related parts of Re-examination dossier for responsible marketed products with minimum supervision.
Note: The following represent common education and experience but not mandatory requirements.
- Typically requires a degree (e.g., BS, BA, MSc or PhD) or professional qualification in a health science field (e.g., nursing or pharmacy) or a relevant scientific/technical discipline (e.g. biology, chemistry, or neuroscience).
- Shows proficiency in verbal and written communication, including Microsoft Excel, Word, and Power Point.
- Shows good analytical thinking skills, attention to detail, teamwork, initiative, and basic project management skills; maintains confidentiality; maintains meticulous attention to project deadlines.