募集要項
- 仕事内容
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• Plan PMS in compliance with GPSP regulations and timely as planned and prepare re-examinations dossier and required materials under drug re-examination system appropriately
• Lead/Manage preparation for Re-examination dossier and inspection readiness
• Ensure the preparation of local periodic safety reports and coordinate a review cycle with the global product responsible person at GPV
• Establish local inspection readiness, participate in PV audits and PV/GPSP inspections as required and contribute to CAPA processes as appropriate
• Lead strategy development and implementation from short and mid-long perspectives so that every Company member can comply with regulation and continuously contribute to close medical safety gap for patient
• Lead to improve business process to ensure efficiency, transparency, compliance, and insightfulness through cross-functional collaboration and data utilization
• Lead to empower individuals and attractive for those who are not only safety and regulatory expert but also can proactively lead him/herself and team and key stakeholders
• Lead to plan and execute PMS strategy from both short and mid-long perspectives so that PMS strategy continuously contribute to close medical needs for patient based on domestic and overseas academic trends and clinical needs, which provides valuable information from medical, scientific, and social perspectives
• Plan to ensure providing scientific evidence valuable for both HCPs and Patient through company / global-wide collaboration (e.g. collaboration with strategy and operations) with customer centric approach.
• Lead strategic design of PMS aligned with MA and MKT teams in regard to usage of RWE collected as part of PMS. She/He co-leads with Epidemiology team the strategic design of database and analysis, for future communication.
• Ensures that insights from PMS activities are collected, analyzed and appropriately shared within the organization
Etc..
- 応募資格
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- 必須
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日本の医師免許をお持ちの方で臨床医の経験が10年以上があり、かつ製薬会社での安全管理部門での経験が1年以上ありかつ医薬品の開発、またはmedical affairsでの経験が３年以上（なおPMSの経験は問わない）
PJ leadの経験
PMSに対して興味があること
English: Fluent (speaking CEFR level : B2)
- 歓迎
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製薬会社での安全管理部門での経験が3年以上、また部下のmanagementがあること
公衆衛生での学位、疫学の学位、知識があること
- 雇用形態
- 正社員
- 勤務地
- Tokyo
- 年収・給与
- ￥10,000,000 – 15,000,000（スキル・ご経験により決定）
- 待遇・福利厚生
- Social insurance
- 休日休暇
- Full 2 holiday week system (Sat/Sun) national holidays, New year’s holiday, Annual Leave
- 選考プロセス
- Resume screening and 2-3 interviews
