Drug safety Staff/安全性評価 【製薬オンライン】製薬会社・製薬メーカー・製薬企業・医薬品・医療機器等の製薬・医療業界の求人転職サイト

受付時間 平日9時~20時まで 土曜9時~17時まで 03-6278-8721

製薬業界専門の転職・求人サイト 製薬Online.com
最終更新日: 2017年 12月 15日





Drug safety Staff

Manage case processing activities for NBI’s investigational and marketed products including case submission to GPV and PMDA according to company’s internal procedure and local regulation.


・Receive and triage safety information regarding NBI’s investigational compounds and marketed products
・Process and complete assessment of all adverse events according to local GVP
・Report AE cases to GCM and PMDA according to BI SOP and local GVP
・Submit literature report/ overseas action taken report to PMDA according to local GCP/GVP
・Conduct follow up request of adverse events to medical representatives
・Manage and oversee process and quality of case processing vendor
・Maintain PV database/system
・Prepare safety monitoring plan for clinical trials sponsored by company
・Conduct safety monitoring for investigational compounds under development as a sponsor
・Serve as a TM PV for local medical sub team
・Lead preparation of J-RMP and its updates in close collaboration with GPV and NBI’s relevant functions
・Assess effectiveness of risk minimization action plan
・Assess safety information except individual cases and prepare literature report and overseas action taken report
・Prepare aggregate reports such as J-PSUR (GVP), J-DSUR and Unlisted non serious ADRs aggregate report
・Prepare Reexamination dossier (GVP part) and be responsible for GPSP inspection
・Serve as a member of pharmacovigilance working group for non international products
・Manage inquiries from health authorities and health care professionals


  • ・Knowledge of local and international PV regulation: Familiarity with ICH/local guidelines and PMDA/MHLW notifications
    ・Excellent command of English language:
    ・Evaluation of safety information including individual case safety reports: 3-5 years Pharmacovigilance/drug safety experiences
    ・Proactive and assertive attitude
    ・Team- and networker


  • 応相談


  • 若干名


  • 正社員


  • 東京


  • 当面なし


  • 8:45~17:20


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