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RGF is a global brand of RECRUIT Japan

Job Description

Company Overview
【糖尿病領域シェアNo.1】定着率◎/ヨーロッパ系製薬メーカー

Job Description
- The role of the PMS group is to ensure re-examination system including planning and execution of PMS, periodic safety report and re-examination dossier. These activities must be conducted properly based on the related regulations such as PMD act, GVP/GPSP and company SOP.
- To establish proper use of the product by collecting, evaluating information for the marketed product’s safety, effectiveness, and the quality, etc., and to feedback the information to customer.
- 製造販売後調査グループの役割は、製造販売後調査の立案及び実行、安全性定期報告や再審査申請資料の作成を含む、再審査制度に関連する活動を確実に実施することである。これらの活動は医薬品医療機器法、GVP/GPSP及び当社SOPに基づき適切に実施されなければならない。
- 医薬品の安全性、有効性、品質に関する情報の収集及び評価を実施し、医薬品の適正使用を推進する。

Tasks /業務の詳細:
- Planning and implementation of PMS
- Submission of re-examination dossier 再審査申請
- Periodic safety report/RMP 安全性定期報告書及びRMPの作成
- GPSP related task GPSP関連業務

Other:
- Respond to the request for providing information related to PMS
- Global/local SOP review
- Attend PV/GXP audit

その他の職務内容:
- 情報提供依頼への対応
- SOPレビュー
- PV/GXP audit対応

Requirements
Experience:
Experience in PMS, clinical development or safety for at least 5 years or more

Knowledge:
- Acknowledge of GPSP and related regulations.
- Medical and pharmaceutical knowledge related to company products and related fields

Education:
Bachelor's degree in science (Master's degree preferred)

Language:
Native japanese with Business level English

PC Skills:
Business level skills in MS-Word, MS-Excel, MS-PowerPoint

Competency:
1) Communication - Strong communication skill to involve other units is required to plan and execute PMS
2) Collaboration - Recognizes and reinforces the values and importance of gaining and leveraging multiple perspectives when planning and executing work activities
3) Innovation and improvement- Proactively looks for continuous improvement opportunities
4) Drives performance - Plans multiple projects with clearly defined components (goal, action, etc.) and executes them in ways that meet defined objectives

Others:
- Strong sence of compliance is essential
- Experience of PMS staff is preferred
- Data Management, statistics and/or epidemiology preferred
- Medical writing skill is a plus