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GPV Management of a Global Activity

年収：1000万 ～ 1500万

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特集求人

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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
部署・役職名 GPV Management of a Global Activity
職種
業種
勤務地
仕事内容 I - JOB SUMMARY
The Japan Case Management Lead is a member of the Japan PV Operations Leadership Team and reports to the Japan PV Operations Lead. He/She is responsible to implement and manage the case processing operation in Japan including case management for marketed and developing products, safety evaluation, PMDA reporting, Product Technical Complains (PTC) management of medical device/drug device combination products, PV inspection/audit and outsourcing vendor management.
He/She contributes to safety management activities in cooperation with Global Pharmacovigilance (GPV), HA (Health Authorities), partner companies and other functions in compliance with global procedures and local regulatory PV requirements.

Responsibilities:
1. Manage properly Japan case processing operation including of ICSR with pharma products/vaccine and PTC with medical device/drug device combination products
Encourage improvement of case handling workflow for AE and PTC
Review and improve/streamling case management process
Case Management expert for all HA inspection inquiry and internal audit impacting JP case processing activities
Case Management expert leading all discussions involving internal/external stakeholder and Partner company about case management
2. Relevant outsourcing vendor management
Control and enhance the quality of outsourcing vendors. As necessary, request CAPA, revise of related manuals and provide trainings to the external vendors.
Monitor the daily vendor activities to improve the quality of the safety information to be entered into PV safety system.
Work jointly with the global case management team to align strategies in regards to vendor management
3. Relevant PV activities
Actively execute the relevant PV activities and projects with strong leadership
Promote efficiency of tasks of the entire team
応募資格

【必須（MUST）】

II – KNOWLEDGE, SKILL, FORMAL EDUCATION & EXPERIENCE
1. Knowledge And Skills:
Experience
Knowledge of global and local PV regulations, PTC regulations
Strong knowledge of the case management and medical safety evaluation in clinical trial and marketed products
Knowledge of PV safety system
Appropriate experience of periodic reports, safety evaluation, risk management and communication with HA.
Knowledge of Project management or experience
Competencies
Skill of ICSR evaluation (seriousness, relatedness, unexpectedness and MedDRA coding) and PMDA reporting as using PV safety system and reporting for medical device malfunction
Skill of fluent verbal and writing communication in English

2. Formal Education And Experience Required:
Science degree with 5 or more years’ experience of pharmacovigilance/PTC management/post-marketing study/clinical development
People management experience

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
受動喫煙対策

喫煙室設置
更新日 2024/03/27
求人番号 3407254

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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