Drug Safety Group Pharmacovigilance, Medicine/ファーマコビジランス 【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: 2019年 05月 24日

求人情報

ファーマコビジランス

新着

求人管理No.013485

会社概要

Drug Safety Group Pharmacovigilance, Medicine

最適な運用戦略、研修計画、将来のシステム設計などを分析し、医薬品安全性システムのためのソリューションを提案/促進/実行

募集要項

・Manage case processing activities for investigational and marketed products including case submission to GPV and PMDA according to internal procedure and local regulation.
・Conduct 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
・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
・Conduct case processing activities and case submission to Global Case Management and PMDA within reporting timeline
・Conduct dissemination of safety information including SUSARs and IND reports to study sites/investigators in collaboration with COJ
・Set up case processing process for clinical trials including consultation with PMDA and coordination with CRO
・ Ensure communication of local safety profile of investigational and marketed compounds to stake holders including GPV TA
・Maintain PV database including system update according to strategy and international regulation

募集条件

  • ・Bachelors Degree
    ・Knowledge of local and international PV regulation
    ・Knowledge of local and international NIS study
    ・Excellent command of English language
    ・Evaluation of safety information including individual case safety reports
    ・ Proactive and assertive attitude
    ・Team- and networker
    ・TA experience in research or industry setting
    ・3+years’ experience in pharmacovigilance

勤務開始日

  • 応相談

採用人数

  • 1

勤務地

  • 東京

勤務時間

  • フレックス制度あり 

給与

  • ご経験に応じての額となります。