Safety Management Specialist – GVP (Heart Recovery)

About the role

Johnson & Johnson is seeking a Safety Management Specialist focused on GVP activities for heart recovery products. The role is based in the Tokyo office and reports to the Safety/GVP manager, supporting post‑market safety and compliance in Japan.

Key responsibilities

• Create and submit adverse event reports to the PMDA.
• Handle, assess, and investigate customer complaints and safety issues.
• Maintain and update Japanese IFUs and user manuals.
• Control documents, procedures, and records related to GVP and post‑market activities.
• Collaborate with product assurance and post‑market engineering teams at the US headquarters.
• Obtain investigation results from the US and prepare customer letters.

Required profile

• Minimum 2 years of GVP and/or post‑market engineering experience in the medical industry.
• Good knowledge of GVP ordinances and basic understanding of the Japan PMDA Act and QMS ordinance.
• Basic English reading and writing skills for email communication and translation of complaint information.
• Basic PC skills, including Microsoft Office applications.

Required skills

• English reading and writing.
• Microsoft Excel.
• Microsoft Word.
• Microsoft PowerPoint.
• Microsoft Access.
• Microsoft Outlook.