【マネージャー】Medical IT/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 01月 19日

求人情報

ファーマコビジランス

求人管理No.011996

会社概要

【マネージャー】Medical IT

外資製薬メーカにて製品安全リスクマネジメント(PV)に関わるIT業務を担当いただきます。

募集要項

・Leading project planning and implementation of Japan local IT projects for these functions.
・Coordinating with external vendors and ensuring they deliver the services for the IT projects.
・Coordinating with business functions to understand and capture the user requirements and user acceptance of the technology solutions provided to them.
・Collaborating with the Global IT team for implementation of Global projects where the project scope also involves Japan rollout.
・Support existing applications that are Live. Coordinate with the vendors hosting the solution or providing technical solutions to fix the issues reported by the Business users.
・Prepare the Computer System Validation documentation required for the GxP systems. Coordinate with the IT Validation Manager and Quality Assurance for assistance and approval of the CSV documents.
・Assist in capturing the new business needs and budget estimate preparation.
・Track and monitor the contracts and agreements of external vendor hired for the Japan IT project.
・Local IT Business Partnering and system support of Regulatory Affairs, Quality and R&D as member of Japan IT team.

募集条件

  • 【必須要件】
    ・7 years in IT. Atleast 3 years to 5 years in supporting and managing Japan PV IT systems.
    ・Implemented projects and supported IT systems and handled user issues in PV and or Medical and Clinical systems.
    ・Good English Speaking, Reading & Writing skills, along with fluent Japanese language skills.
    ・Worked with global team on global IT projects.
    ・Worked on Safety system data migration projects.

    【歓迎要件】
    ・Worked in Pharmaceutical company or IT consulting company providing services to Pharmaceutical companies in PV, Medical, Clinical, Regulatory areas.
    ・Knowledge of PMDA regulations in PV and or Medical domain. Knowledge of E2B R3 and IDMP regulations.
    ・Computer Science graduate.

    【語学力】
    ・英語ビジネスレベル以上(TOEIC 740点以上) グローバルとのやりとりが多く発生します。

    【学歴】
    ・大学卒業以上

勤務開始日

  • 応相談

採用人数

  • 若干名

雇用形態

  • 正社員

勤務地

  • 東京

転勤有無

  • 当面なし

勤務時間

  • 9:00~17:30 ※フレックスタイム制あり

給与

  • 900~1200万円