求人情報

安全性情報・PMS

外資系製薬メーカー Staff,Safety Science & PMS Department, Pharmacovigilance Division, R&D

[ID:01685]

会社区別 欧州系製薬メーカー 職種 Staff,Safety Science & PMS Department, Pharmacovigilance Division, R&D
勤務地 大阪、東京 年収 ~900万円(前職考慮)
資格・要件 ≪必須≫
- Relevant safety experience or experience elsewhere in Pharmaceutical industry
- Cross-functional project team experience
- Thorough knowledge of the Pharmacovigilance or drug development process
- Scientific knowledge sufficient to understand all aspects of safety issues
≪歓迎≫
- Pharmacovigilance activities, drug development or regulatory affairs experience in outside of Japan
- Working with external bodies, such as co-marketing companies and advisory board members, as a leading person

■能力
≪必須≫
- Written and verbal communication skills
- Leadership skill
- Problem solution skill
- Logical thinking
- Understanding of PMD Act, relevant regulations, GVP/GPSP and guidelines
- Basic knowledge of statistic analysis
- Expertise of medical/pharmaceutical science in general

■語学
≪必須≫
- Business English (Speaking level 6 or above)
職務内容 Post Marketing PV & Safety Scientist is responsible for leading to execution of Pharmacovigilance activities of the products basically post marketing phase including re-examination properly and timely, and for ensuring the Patient’s safety by:
- Maintaining the Risk Management plan of the products in Japan based on the PV activities’ results and other information
- When the safety issue arises, lead to define the appropriate safety measurement through the communication with the related internal parties including Global patient safety with relevant in-house members and external parties (including co-promotion company, PMDA and MHLW etc.)
- Managing quality Pharmacovigilance deliverables such as RMP(Revision), PMS (interim and final)report , J-PSUR and Re-examination package of the assigned products/projects throughout the product’s lifecycle
- Work on management of CEI/sCEI operation, PMS data management, management of EPPV, or communication of Safety Assurance Measure as PV associate member.