安全性・PMS、薬物動態学研究部門/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: 2018年 08月 14日
友人紹介キャンペーン 期間:2018年8月1日(水)から8月31日(金)

求人情報

ファーマコビジランス

求人管理No.012573

会社概要

安全性・PMS、薬物動態学研究部門

適切かつタイムリーに再検査を含む製品のPharmacovigilance活動の遂行につながり、患者の安全を確保

募集要項

Post Marketing PV & Safety Scientist is responsible for leading to execution of Pharmacovigilance activities of the products basically post marketing phase including re-examination properly and timely, and for ensuring the Patient’s safety by:
・ Maintaining the Risk Management plan of the products in Japan based on the PV activities’ results and other information
・ When the safety issue arises, lead to define the appropriate safety measurement through the communication with the related internal parties including Global patient safety with relevant in-house members and external parties (including co-proportioned company, PMDA and MHLW etc) .
・ Managing quality Pharmacovigilance deliverables such as RMP(Revision), PMS (interim and final)report ,J-PSUR and Re-examination package of the assigned products/projects throughout the product’s lifecycle
・ Work on management of CEI/sCEI operation, PMS data management, management of EPPV, or communication of Safety Assurance Measure as PV associate member.

募集条件

  • 【Mandatory】
    ・ 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

    【Mandatory】
    ・ Bachelor’s Degree in Science or related discipline

    【Mandatory】
    ・ Communication/negotiation skill
    ・ Leadership skill
    ・ Problem solution skill
    ・ Logical thinking

    【Mandatory】
    ・ Business English (Speaking level 6 or above)

    Others:
    【Mandatory】
    ・ Understanding of PMD Act, relevant regulations, GVP/GPSP and guidelines
    ・ Basic knowledge of statistic analysis
    ・ Expertise of medical/pharmaceutical science in general

勤務開始日

  • 応相談

雇用形態

  • 正社員

勤務地

  • 東京、大阪

転勤有無

  • 当面なし

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。