募集要項
- 仕事内容
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Basic purpose of the job
• Manage case processing activities for our investigational and marketed products including case submission to GPV and PMDA according to the internal procedure and local regulation.
• Conduct safety risk management activities for assigned compounds by establishing and maintaining Risk Management Plan which fulfils compliance with the 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.
Accountabilities
• Conduct case processing activities and case submission to Global Case Management and PMDA within reporting timeline
• Conduct dissemination of safety information including SUSARs and IND reports to study sites/investigators in collaboration with CD&O
• Set up case processing process for clinical trials including consultation with PMDA and coordination with supplier
- 応募資格
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- 必須
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• Bachelors Degree
• 3+years’ experience in pharmacovigilance
• Knowledge of local and international PV regulation
• Knowledge of local and international NIS study
• Excellent command of English language
• Evaluation of safety information including individual case safety reports
• Proactive and assertive attitude
• Team- and networker
- 雇用形態
- 正社員
- 勤務地
- 東京都
- 年収・給与
- 想定年収：800万円～1300万円程度（応相談）※ご経験・スキルに応じて検討します。
- 待遇・福利厚生
- Social insurance, Remote work, Flex time
- 休日休暇
- Full 2 holiday week system (Sat/Sun) national holidays, New year’s holiday, Annual Leave
