Integra LifeSciences

  • GVP Specialist

    Vacancy ID
    2018-26292
    Location
    JP-Tokyo
    Position Type
    Regular Full-Time
    Category
    Regulatory Affairs
  • Overview

    This GVP Specialist executes all GVP tasks regulated in GVP requirements.  This position is based in Tokyo, Japan.

     

    Responsibilities

     

    Key Duties and Responsibilities

    • GVP Tasks and Product Complaint Handling
    • Execute GVP tasks regulated in GVP requirements
    • Execute product complaint handling
    • Communicate with responsible person in medical institute with regard to product complaint
    • Create and revise Package Insert (J-IFU)
    • Notice and communicate with PMDA for Package Insert

    Qualifications

     

    Education and Experience

    • Minimum level of education needed to perform duties
    • Minimum 5 year GVP experience in Pharmaceutical / Medical Device (Class IV) Industries

     

    Essential Skills and Abilities

    • Excellent verbal and written communication skills
    • Ability to multiple tasks, prioritize and work under pressure
    • Strong negotiation skills with Japan authorities (MHLW, PMDA, TMG, Notified body)
    • Good organization skills and ability

     

    Competencies

    • Business level of English language skill
    • Native level of Japanese language skill
    • Computer skills – MS-Word, Excel, PowerPoint

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