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【1080～1440万円】PV Manager
| Hiring Company | 外資スペシャリティファーマ |
| Location | Tokyo - 23 Wards |
| Job Type | Permanent Full-time |
| Salary | 10 million yen ~ 14 million yen |
Job Description
【求人No NJB2360855】
主な業務は、臨床試験の安全報告管理、NDA関連のリスク管理計画作成、PMDA対応、市販後の安全対策実施、PVシステム運用管理、チームの育成とリソース配分です。患者安全とコンプライアンス重視の文化醸成も担います。
General Requirements
| Minimum Experience Level | No experience |
| Career Level | Mid Career |
| Minimum English Level | Business Level |
| Minimum Japanese Level | Native |
| Minimum Education Level | Bachelor's Degree |
| Visa Status | Permission to work in Japan required |
Required Skills
【Required】
PV experience in a pharmaceutical company （both GCP and GVP preferred）.
Strong understanding of Japanese regulations （GVP/GCP PMDA/MHLW）.
Experience creating/reviewing PV documents （RMP DSUR PSUR CTD）.
Experience managing a team OR leading cross functional projects.
Proven people management experience.
Native level Japanese; business level English.
【Preferable】
Experience leading regulatory inspections.
Experience in working a global PV organization.
Safety assessment or signal detection knowledge.
Medical pharmacy or life science background.
Bachelor’s or master’s degree in pharmacy Medicine or a related scientific field.
Ph.D. degree is preferred but not required.
【License（s） / Certification（s）】
Pharmacist Preferred
MD Preferred
Job Location
- Tokyo - 23 Wards
Work Conditions
| Job Type | Permanent Full-time |
| Salary | 10 million yen ~ 14 million yen |
| Holidays | 【有給休暇】有給休暇は入社時から付与されます 入社7ヶ月目には最低10日以上 【休日】完全週休二日制 土 日 祝日 年末年始 … |
| Industry | Pharmaceutical |
Job Category
Company Details
| Company Type | International Company |
