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Senior Staff or Manager, PMS

Publication date 2020/06/9

Tokyo,10.0M ~ 12.0M

European Leading Private Pharma

Mission:

1: Lead/Manage GPSP activities such as data collection, progress tracking, budget tracking, vendor management, Re-examination and process standardization according to the internal procedure and local regulation

2: Plan and conduct post marketing surveillance studies as additional PV plan based on safety specification in compliance with GVP and GPSP regulations

Accountabilities and Related Performance Indicators:

Ensure timeline and quality of GPSP operational activities including study set-up, CRF collection, progress tracking, budget tracking and vendor management
Timeline and quality of GPSP activities

Lead/Manage preparation for Re-examination dossier and inspection readiness
Ensure preparation for re-examination inspection readiness

Standardize GPSP process and optimize resource and budget for GPSP activities
Quality and Efficiency of GPSP activities

Establish and support local inspection readiness, participate in PV audits and PV/GPSP inspections as required and contribute to CAPA processes as appropriate
Ensure inspection readiness

Ensure the preparation of local periodic safety reports and coordinate a review cycle with the global product responsible person at GPV
Ensure local periodic report preparation in time and provide quality documents

Conduct PMS in compliance with GPSP regulations and timely as planned and prepare re-examinations dossier and required materials under drug re-examination system appropriately
Ensure quality PMS and re-examination in a timely manner

Must
- 3年以上の市販後調査関連業務経験
- 生物化学系大学卒業もしくは薬剤師免許保有者
- PMSのオペレーション業務経験者(契約・進捗促進、MRへの指示、施設からの問い合わせ対応、調査関連経費立案・消化管理、データチェックに関する疑義対応、EDC調査運用経験等)

Desirable

- 試験計画書/報告書/安全性定期報告書/再審査申請資料作成に一部関与した経験
- 適合性調査/PMDAからの照会事項対応に一部関与した経験

Health Insurance, Pension, Bonus

Required Skills
- Knowledge of local and international GVP/GPSP regulation
- Knowledge of local and international NIS study
- Proactive and assertive attitude

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