[quality] Safety Management Specialist-gvp [heart Recovery]

Johnson & Johnson Johnson & Johnson · Pharma · Chuo-ku, Tokyo, Japan

This role is responsible for GVP (Good Vigilance Practice) activities, including handling complaints and reporting adverse events to the competent authority in Japan. It involves collaborating with US headquarters, maintaining documentation, and ensuring compliance with Japanese regulations like PMDA Act and QMS Ordinance. The role requires experience in the medical industry, knowledge of GVP, and English reading/writing skills.

What you'd actually do

  1. Creating and submitting adverse event reports to PMDA.
  2. Handling and assessing complaints and safety issues
  3. Maintaining and updating Japanese IFUs and user manuals
  4. Controlling documents, procedures, and records related to GVP and post-market activities.
  5. Collaborating with product assurance and post-market engineering teams in the US headquarters.

Skills

Required

  • 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)

Nice to have

  • knowledge of cardiovascular related products
  • Business level English communication skill

What the JD emphasized

  • GVP Ordinances
  • adverse event reporting
  • Japan PMDA Act
  • QMS Ordinance