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| 部署・役職名 | PV Manager |
|---|---|
| 職種 | |
| 業種 | |
| 勤務地 | |
| 仕事内容 |
Overall objective： ・Manage and promote the overall Pharmacovigilance activities in Japan with consideration of global/local regulatory requirements including GCP, GVP and GPSP. ・To assist the SCP to assume responsibilities and tasks related to role as a Safety Contact Person as described in LEO QMS documents. In case of temporary absence of the SCP, to assume the duties of SCP. Role and responsibilities： ・To implement appropriate Pharmacovigilance activities of Marketed Products and Investigational Products in compliance with GVP, GPSP, GCP and relevant regulatory requirements and SOPs ・Be responsible for overall management of evaluation and reporting of domestic and foreign individual case reports of Marketed Products and Investigational Products ・Be responsible for overall management of evaluation and reporting of domestic and foreign research reports and measures taken overseas ・Provide safety information to relevant parties ・Implement Pharmacovigilance Agreements ・Maintain PV Awareness and Training ・Ensure PV Audit and Inspection Readiness ・Plan, process and report Aggregate Reports to global and competent authorities ・Create local Risk Management Plans ・Management of GPSP related activities including handling of Specific Use－Result Survey and Reexamination |
| 労働条件 | 詳細は面談でご説明致します。 |
| 応募資格 |
【必須（MUST）】 ・At least 3 years of experience in Pharmacovigilance related activities・At least 3 years of experience in Post－Marketing Surveillance related activities ・Held responsibility in relation to operation of Pharmacovigilance activities including safety profile of Marketed and Investigational products and management of relevant staff ・Understanding of relevant legislation with regards to Pharmacovigilance under GVP, GCP and GPSP ・Possess excellent interpersonal, verbal, and written communication skills. Able to research, compile and provide safety information in a clear concise manner to the local/global team as appropriate. ・Possess coaching skills necessary for implementation of human resources development of subordinates ・Management capability of sub ordinates operation including progress management ・Experience of GCP, GVP, GPSP inspection by the competent authority |
| リモートワーク | 可 「可」と表示されている場合でも、「在宅に限る」「一定期間のみ」など、条件は求人によって異なります |
| 受動喫煙対策 | 屋内禁煙 |
| 更新日 | 2025/12/12 |
| 求人番号 | 6331595 |
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- 自己PR欄に、2024年と2025年度におけるビズリーチからのサポート実績を記載しております。 ビズリーチで転職サポートがした6割以上の方が東証一部上場企業にご入社いただいております。 どのエージェントから選考を受けられるか悩まれましたら、まずはご相談下さい。
- (2025/01/09)
転職・求人情報の詳細をご覧になる場合は会員登録（無料）が必要です