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Job Description:

Job Responsibilities:

GVP staff is responsible for GVP activities including complaint handling and adverse event reporting to competent authority in Japan. He/she works at Tokyo Office closely and reports to Safety/GVP manager.

Principle Duties and Responsibilities:

• Creating and submitting adverse event reports to PMDA.
• Handling and assessing complaints and safety issues
• Maintaining and updating Japanese IFUs and user manuals
• Controlling documents, procedures, and records related to GVP and post-market activities.
• Collaborating with product assurance and post-market engineering teams in the US headquarters.
• Obtaining complaint investigation results from the US headquarters and creating customer letters.

Job Qualifications:

• Minimum 2 years of GVP and/or post-market engineering experience in the medical industries
• Good knowledge about GVP Ordinances and adverse event reporting
• Basic knowledge of Japan PMDA Act and QMS Ordinance
• English reading and writing skills (e.g., e-mail communication, translation of complaint information)
• Basic PC skills (Microsoft Excel, Word, PowerPoint, Access, Outlook)

• Preferred to have knowledge of cardiovascular related products
• Business level English communication skill

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