Global Pharmaceutical Company
- Lead/Manage case processing activities for Company's investigational and marketed products including case submission to GPV and PMDA according to BI's internal procedure and local regulation.
- Lead/manage safety risk management activities for assigned compounds by establishing and maintaining J-Risk Management Plan which fulfils compliance with BI's internal procedures and local regulation
- Lead/Manage PV business operational tasks including SOP & Training and Quality Check of deliverables. Ensure quality of service level provided by vendor and maintain PV system. Ensure inspection readiness from regulatory authorities
- Ensure case processing activities and case submission to Global Case Management and PMDA within reporting timeline
- Ensure dissemination of safety information including SUSARs and IND reports to study sites/investigators in collaboration with COJ
- Set up case processing process for clinical trials including consultation with PMDA and coordination with CRO
- Maintain PV database including system update according to BI's strategy and international regulation
- Ensure communication of local safety profile of Company's investigational and marketed compounds to stake holders including GPV TA
- Develop and update J-RMP in close collaboration with GPV TA and ensure assessment of local safety profile of Company's products within assigned TA
- Implement and monitor risk minimization measures as necessary for assigned TA products at local level, coordinate safety issues with the local management, the regional PV Head and GPV
Degree / Education
- Bachelor's Degree
- Medicine Major
- More than 15 years' experience in working in PV function.
- More than 5 years' experience in managing people.
Required Capabilities (Skills, Experiences, Competencies)
- Knowledge of local and international PV regulation
- Excellent command of English language
- Substantial knowledge of evaluation of safety information including individual case safety reports
- Problem resolution skill and crisis-management skills
- Japanese Native is highly preferable
- English：TOEIC score: more than 800
[Preferred Knowledge, Skills and Abilities]
- Experience in managing CRO is preferable.
- Proactive and assertive attitude
- Team- and networker
※Experiences and skills will be considered
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