Risk Management & Safety Scientists/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 03月 26日
期間限定!2019年3月31日まで最大10万円の転職お祝い金を進呈!

求人情報

ファーマコビジランス

求人管理No.013179

会社概要

Risk Management & Safety Scientists

Safety surveillance representatives lead to execution of pharmacovigilance activity, and communication of Safety Assurance Measure basically during EPPV period.

募集要項

Risk Management & Safety Scientists are responsible for setting product safety specifications and for delivery of local Risk Management Plan (RMP), and J-PI (safety parts) to optimize market access from patient safety perspective in Japan.
RMP Team Leads manage setting the project safety strategy in view of ‘Benefit and Risk valance’ of each product by planning the appropriate risk minimization activities and pharmacovigilance plan including regulatory mandatory pharmacovigilance studies collaborated with JPT and Global Strategic Safety Management Team (SSaMT) Leads for JNDA preparation.
Safety surveillance representatives lead to execution of pharmacovigilance activity, and communication of Safety Assurance Measure basically during EPPV period.

募集条件

  • ■Experience
    【Mandatory】
    ・Bachelor’s or higher Degree in Science or related discipline
    ・Relevant safety experience or experience elsewhere in Pharmaceutical industry
    ・Cross-functional project team experience
    ・Thorough knowledge of the Pharmacovigilance or drug development process
    ・Written and verbal communication skills
    ・Scientific knowledge sufficient to understand all aspects of safety issues

    【Nice to have】
    ・Pharmacovigilance activities, Drug development or regulatory affairs experience in outside of Japan
    ・Working with external bodies, such as co-marketing companies and advisory board members, as a leading person

    ■Skill-set
    【Mandatory】
    ・Communication/negotiation skill
    ・Leadership skill
    ・Problem solution skill
    ・Logical thinking
    ・Business English (Speaking level 6 or above)
    ・Understanding of PMD Act, relevant regulations, GVP/GPSP and guidelines
    ・Basic knowledge of pharmacoepidemiology and statistical analysis
    ・Expertise of medical/pharmaceutical science in general

免許・資格

  • Expertise of medical/pharmaceutical science in general

勤務開始日

  • できるだけ早く

採用人数

  • 複数名

雇用形態

  • 正社員

勤務地

  • 東京・大阪

転勤有無

  • なし

勤務時間

  • フレックス勤務

給与

  • ご経験に応じます。