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| 部署・役職名 | 【幅広い業務・少数精鋭編成の品目担当】Drug Safety Manager |
|---|---|
| 職種 | |
| 業種 | |
| 勤務地 | |
| 仕事内容 |
こんな方なら向いている ー 持続可能な成長を優先し、収益優先よりも研究開発への投資を重要視するコアバリューを持っている環境を求める方 ー 大手外資製薬でも縦割りの分業ではなく、幅広い業務内容を担当したい方 ー 柔軟的な働き方をしながら業務に携わりたい方 Basic purpose of the job － Manage case processing activities for investigational and marketed products including case submission to GPV and PMDA according to the company's internal procedure and local regulation. － Conduct safety risk management activities for assigned compounds by establishing and maintaining J－Risk Management Plan which fulfils compliance with the company’s internal procedures and local regulation － Manage PV business operational tasks including SOP ＆ Training and Quality Check of deliverables. Ensure quality of service level provided by vendor and maintain PV system Main responsibilities － In time ICSR reporting to GPV/PMDA － In time SUSARs/IND reports dissemination to study sites － Ensure in－time set up of case processing process － Maintain PV database including system update according to the company’s strategy and international regulation － Ensure communication of local safety profile of the company’s investigational and marketed compounds to stake holders including GPSPV TA － Ensure global and local aligned risk management activities － Develop and update J－RMP in close collaboration with GPSPV TA and ensure assessment of local safety profile of the company’s products within assigned TA － Implement and monitor risk minimization measures as necessary for assigned TA products at local level, coordinate safety issues with the local management, the regional PSPV Head and GPSPV － Ensure J－RMP timeline and quality － Ensure global and local aligned risk management activities － Ensure the preparation of local periodic safety reports and coordinate a review cycle with the global product responsible person at GPSPV for international products if appropriate － Ensure local periodic report preparation in time and provide quality documents － Establish and support local inspection readiness, participate in PV audits and PV/GPSP inspections as required and contribute to CAPA processes as appropriate － Ensure local inspection readiness － Conduct high－level trainings on regulations, global/ local PV SOP － Organize trainings to improve knowledge and skills of PSPV staff in cooperation with the corporate training function － Prepare SOPs, Wis, WMs satisfying Corporate SOPs and local regulations, and collaborate with other teams within PSPV or Clinical teams and Marketing teams on safety issues |
| 応募資格 |
【必須（MUST）】 － Knowledge of local and international PV regulation－ Knowledge of local and international NIS study － 3＋years’ experience in pharmacovigilance － Bachelor’s Degree － Business level proficiency in English － Evaluation of safety information including individual case safety reports － Proactive and assertive attitude, a team player |
| リモートワーク | 可 「可」と表示されている場合でも、「在宅に限る」「一定期間のみ」など、条件は求人によって異なります |
| 受動喫煙対策 | その他 「就業場所が屋外である」、「就業場所によって対策内容が異なる」、「対策内容は採用時までに通知する」 などの場合がその他となります。面接時に詳しい内容をご確認ください |
| 更新日 | 2024/11/19 |
| 求人番号 | 4051886 |
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転職・求人情報の詳細をご覧になる場合は会員登録（無料）が必要です