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Local Safety Officer

年収:800万 ~ 1200万

採用企業案件

採用企業

サノフィ株式会社

  • 東京都

    • 資本金500百万円
    • 会社規模501-5000人
  • その他
  • 医薬品メーカー
部署・役職名 Local Safety Officer
職種
業種
勤務地
仕事内容 Medical safety management of GPV local products:
Serve as a clinical and post-marketing medical safety expert in the country
Accountable for all signal management activities in the country & ensures that the local product labels and risk management plans are properly aligned with the benefit risk of the products.
Responsible of the safety surveillance of assigned GPV global and local products, in compliance with local regulations and Sanofi group procedures. This includes (but not limited to):
Handling of local Regulatory Authorities safety queries,
Preparation and writing of periodic safety reports,
Management of safety signal (detection including literature screening, validation, analysis),
Preparation and writing of risk management plans,
Labelling updates,
Health hazard evaluations
Local studies documents
Work in close collaboration with Regions Medical Safety & Processes Coordination Head to ensure appropriate assessment of Safety information related to Sanofi local products.
Serve as the back up to country RPP/Local QPPV (if applicable by national regulations) for the products of all applicable Sanofi entities.
Can serve as the CSH back-up where applicable
Local, Region and Global Partnership

Local:
Serves as a back-up to local Responsible Person for Pharmacovigilance as needed
Can act as a back-up to Country Safety Head and/or Region Safety Head when applicable
Represent PV in interactions with local GxP and non GxP functions, to optimize coordination and collaboration in areas of overlapping interests: participate actively to local meetings/committees such as MRPQ meeting (when applicable), deliver presentations and participate in working groups.
Build and maintain robust collaboration/interaction with the in-country partner functions, to carry out and monitor local PV activities, in compliance with PV regulatory requirements and company procedures/guidelines, and particularly:
Secure with Medical Information, Clinical Study Unit, Quality, Marketing and local third party (e.g. CRO, vendors) the detection and transmission to PV unit of incoming PV data in timely manner
Contribute to the development of local implementation plan of additional Risk Minimization Measures (aRMMs) and enable its implementation by working cross-functionally with Country GBU Medical Head (or delegate), the Country Regulatory Manager and other appropriate functions.

Region/Global:
Identify issues or dysfunction in the assigned country(ies) and escalate to Country Safety Head/CSH and/or directly to the RSH/QPPV.
In case of PV outsourcing activities, collaborate with Regions Resources & Budget Lead in -Global PV management office to implement the best outsourced capabilities.
Interact with the Global Safety Officer (GSO) for relevant questions related to the safety profile of Sanofi product originating from HA or any other sources.

Management responsibilities:
Manage PV staff member(s) directly or cross-functionally:
Provide leadership, mentorship and supervision to his/her team (e.g. leading regular team meetings) to ensure transparency and alignment on strategic direction, goals, processes and objectives
Sets up the appropriate resources and qualification of the team, evaluates team performance and fosters training and personal development by effective talent management and recognition
応募資格

【必須(MUST)】

· Can interact with the Global Safety Officer (GSO) for relevant questions
· Can manage PV staff member(s) directly or cross-functionally
· Can represent PV in interactions with local GxP and non GxP functions, to optimize coordination and
collaboration in areas of overlapping interests

アピールポイント 自社サービス・製品あり 外資系企業 女性管理職実績あり 従業員数1000人以上 シェアトップクラス 年間休日120日以上 産休・育休取得実績あり 教育・研修制度充実 マネジメント業務なし 完全土日休み フレックスタイム
受動喫煙対策

その他

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更新日 2024/02/08
求人番号 3275794

採用企業情報

サノフィ株式会社
  • サノフィ株式会社
  • 東京都

    • 資本金500百万円
    • 会社規模501-5000人
  • その他
  • 医薬品メーカー
  • 会社概要

    【設立年月日】2006年1月1日
    【代表者】代表取締役社長 岩屋 孝彦
    【資本金】5億円
    【従業員数】1,969名(2023年3月1日現在)*サノフィ・ジャパングループ 全体
    【本社所在地】東京都新宿区西新宿三丁目20番2号
    【その他事業所】物流センター(埼玉県三郷市、大阪府茨木市)

    【事業内容】医薬品等の製造販売・輸入、研究開発

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