Pharmacovigilance Group Manager - Pharmaceutical Company

勤務地 Tokyo, Japan
職種 正社員
給与 ¥10000000.00 - ¥12000000.00 per annum
専門 ライフサイエンス(医療機器・製薬・化学・ヘルスケア・農業・畜産),
Sub-specialization 安全性試験 / 安全性管理,
お問合せ Yuichi Matsuda
参照 JO-2004-439353
about Yuichi Matsuda

[Company Description]

Global Pharmaceutical Company


[Responsibilities]

Duties:

    1. Lead/Manage case processing activities for Company's investigational and marketed products including case submission to GPV and PMDA according to BI's internal procedure and local regulation.
    2. Lead/manage safety risk management activities for assigned compounds by establishing and maintaining J-Risk Management Plan which fulfils compliance with BI's internal procedures and local regulation
    3. Lead/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. Ensure inspection readiness from regulatory authorities

Responsibilities:

    1. Ensure case processing activities and case submission to Global Case Management and PMDA within reporting timeline
    2. Ensure dissemination of safety information including SUSARs and IND reports to study sites/investigators in collaboration with COJ
    3. Set up case processing process for clinical trials including consultation with PMDA and coordination with CRO
    4. Maintain PV database including system update according to BI's strategy and international regulation
    5. Ensure communication of local safety profile of Company's investigational and marketed compounds to stake holders including GPV TA
    6. Develop and update J-RMP in close collaboration with GPV TA and ensure assessment of local safety profile of Company's products within assigned TA
    7. Implement and monitor risk minimization measures as necessary for assigned TA products at local level, coordinate safety issues with the local management, the regional PV Head and GPV

[Requirements]

Degree / Education

    • Bachelor's Degree
    • Medicine Major

Experience

    • More than 15 years' experience in working in PV function.
    • More than 5 years' experience in managing people.

Required Capabilities (Skills, Experiences, Competencies)

    • Knowledge of local and international PV regulation
    • Excellent command of English language
    • Substantial knowledge of evaluation of safety information including individual case safety reports
    • Problem resolution skill and crisis-management skills

Language

    • Japanese Native is highly preferable
    • English:TOEIC score: more than 800

[Preferred Knowledge, Skills and Abilities]

    • Experience in managing CRO is preferable.

[Desired Characteristics]

    • Proactive and assertive attitude
    • Team- and networker

[Employment Type]

Full time


[Salary]

10M〜12M Yen
※Experiences and skills will be considered


[Location]

Tokyo



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