CRA転職情報
- トップ
- PMS／安全性情報転職情報
- 148073102 PMS MANAGER
PMS／安全性情報転職情報一覧
148073102 PMS MANAGER
| 職種 | PMS MANAGER |
|---|---|
| 会社概要 | 外資製薬メーカー |
| 業務内容 | 1. Establish GPSP or safety part of GCP system and manage each activity. 2. Maintain and review GPSP SOP or safety part of GCP SOP. 3. Manage Safety Evaluation Committee or related safety committee within GPSP. 4. Support to maintain related safety database includes in-house, GLOBAL’ and CRO’. 5. Review PMDA safety documents or PMS documents or related contract, etc. 6. Negotiate safety issues with Authority, other Dept., GLOBAL and co-development/co-marketing companies. 7. Manage MR/CRA training related SOP. 8. Manage GPSP self-inspection activities. 9. Manage reexamination activities with GVP Manager. 10. Manage GPSP or safety part of GCP audit activity. 11. Other related task as necessary or as required by the manager. |
| 応募資格 | · Bachelor degree of sciences, pharmacology, nursing, medical sciences, or equivalent knowledge · JAPANESE fluent speaking, listening, reading and writing skills. ·About 10 years experiences of PMS/ Pharmacovigilance for medicine and/or medical devices. · Any experience of pharmaceutical manufacturer’s association member of “SEIYAkkyo”, “toyakuko”, ETC. · ENGLISH medium class of reading, writing, speaking and listening skills. · Communication, negotiation or presentation skills with PMDA, MHLW AND relating internal division, other companies and Global Drug Safety, medical institutions, e.g., pharmacy, physician, nurse, and other paramedics. · Positive and cooperative attitude. |
| 勤務地 | 東京 | 収入 | 1000万円～1400万円 | その他 |
