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| 部署・役職名 | PMS戦略企画担当者/医薬開発本部ペイシェントセイフティー＆ファーマコビジランス部PMS戦略企画グループ |
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| 職種 | |
| 業種 | |
| 勤務地 | |
| 仕事内容 |
【Basic purpose】 － Lead/Manage GPSP activities such as planning PMS, vendor management, Reexamination and process standardization according to internal procedure and local regulation － Plan post marketing surveillance studies as additional PV plan based on safety specification in compliance with GVP and GPSP regulations and support for PMS execution in collaboration with PMS execution group － Grasp key trends of customer, competitor and regulatory trends and company regarding PMS in Japan and globe from short / mid－long perspective 【Accountabilities】 1.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 2.Lead/Manage preparation for Re－examination dossier and inspection readiness 3.Ensure the preparation of local periodic safety reports and coordinate a review cycle with the global product responsible person at GPV 4.Contribute to establish local inspection readiness, participate in PV audits and PV/GPSP inspections as required and contribute to CAPA processes as appropriate 5.Contribute to strategy development and implementation from short and mid－long perspectives so that every member can comply with regulation and continuously contribute to close medical safety gap for patient 6.Lead to improve business process to ensure efficiency, transparency, compliance, and insightfulness through cross－functional collaboration and data utilization 7.Contribute 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 8.Contribute 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 9.Contribute to 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. 10.Contribute to 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. 11.Contribute to ensure that insights from PMS activities are collected, analyzed and appropriately shared within the organization 12.Contribute to ensures a positive Customer experience by engaging with appropriate functions that support Customer Engagement activities （e.g. S＆O, MA） by continuously keeping communication and establishing an interface or platform that allows improvement of CE and its KPIs 【Regulatory and/or Organisational Requirements】 • Follows government regulations and company standard operating procedures relevant to quality management system （QMS）, Good Post－Marketing Study Practice（GPSP）, good vigilance practice（GVP）. • Be compliant and acts within ethics at all times. 【Job Complexity】 The position requires extensive regulatory, scientific, epidemiologicaland medical knowledge . This needs to take into account needs and requirements of other functions, departments and units. Interfaces: Global patient safety＆ pharmacovigilance, CO＆D Japan, Primary Care Medicine, Specialty Care medicine, LRA, QM, Primary care business unit, Specialty care business unit 【Job Expertise】 5＋years’ experience in pharamacovigilance and PMS Experience of leading PJ and/or taskforce in industry association is preferable. 【Job Impact】 Conduct and Establish internal/external collaborations by sharing best practices 【Minimum Education/Degree Requirements】 Bachelors Degree |
| 労働条件 |
契約期間：期間の定めなし 試用期間：あり（3カ月） 就業時間：8:45～17:20（うち休憩45分間） 休日：土日、祝日 その他各種会社休日あり（年間127日：2025年） 休暇：年次有給休暇（入社初日に6～16日を付与）、慶弔休暇・リフレッシュ休暇等各種有休特別休暇制度あり 残業：あり 給与改定：年1回（4月） 通勤手当：会社規定に基づき支給 社会保険：健康保険、厚生年金、労災保険、雇用保険 |
| 応募資格 |
【必須（MUST）】 Knowledge and experience ・Substantial knowledge about local GPSP/GVP regulation and local and international NIS study・Knowledge and experience of PMS administrative task ・Knowledge and experience of PJ management ・Experience on industry activities （e.g. participating working group across companies） （preferable） ・Excellent command of English language （toeic score more than 700） Skill and Competencies ・Proactive and assertive attitude to establish team and networking ・Problem solving skill ・Analytical skills on industrial trend. ・Conceptual and strategic thinking ・Project management and decision－making skills ・TOEIC score of 700 or higher. |
| 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 | 屋内禁煙 |
| 更新日 | 2026/01/05 |
| 求人番号 | 6461296 |
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