メディカル・バイオ - 薬事申請

Job Description:
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.

■休日：完全週休二日制, 土, 日, 祝日, 年末年始

  <Requirements>
・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)

<Preferences >
・Preferred to have knowledge of cardiovascular related products
・Business level English communication skill

Preferred Skills:
Business Behavior, Compliance Management, Continuous Improvement, Data Analysis, Data Compilation, Detail-Oriented, Execution Focus, Goal Attainment, Internal Controls, Issue Escalation, Process Oriented, Quality Control (QC), Quality Management Systems (QMS), Quality Standards, Regulatory Environment, Report Writing

■職種未経験者：不可