Safety Operation(Senior Manager)/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: 2018年 05月 25日
春の転職支援キャンペーン 期間:2018年1月26日(金)から4月30日(月)

求人情報

安全性評価

求人管理No.012428

会社概要

Safety Operation(Senior Manager)

Report to the head of Pharmacovigilance department, Drug Safety

募集要項

・To ensure excellent regulatory compliance and credibility.
・To contribute on the NDA approval by executing proper safety operation of the
investigational products.
・ Ensuring PV contract management and payment
・ Administration of local SOP/WP
・ Supporting Computerized System Validation on PV system
・ Monitoring quality of case management tasks
・ Group management

募集条件

  • ■Experience
    ・7 years and more of support experience of PV/Clinical Development operation in the
    pharmaceutical industry
    ・3 years and more of experience of staff management
    ・Experience in managing CRO operation essential
    ・Audit experience for medical sites, in-house and vendors if preferable

    ■Knowledge
    ・Mastery of global/local Pharmacovigilance/safety regulatory requirement (Pharmaceutical
    Affairs Law, Enforcement Ordinance and Enforcement Regulations, GCP, GPSP, etc)
    ・Willingness to learn new skills
    ・Strong Japanese writing ability, including medical terms

    ■Competencies
    ・Communication skill including English
    ・Scientific writing skill
    ・ Ability of time management
    ・Ability of CRO management
    ・ Leadership

勤務開始日

  • 応相談

採用人数

  • 1

雇用形態

  • 正社員

勤務地

  • 東京

転勤有無

  • なし

給与

  • ご経験に応じての額となります。