Safety Manager, QMS (#1563)

Role: Safety Manager, QMS

What you'll do

• Execute and maintain Good Vigilance Practices (GVP) and Post-Market Surveillance (PMS) activities in compliance with Japanese regulatory requirements.
• Conduct periodic safety information collection, review, and assessment required for PMS.
• Prepare and submit vigilance reports (e.g., E2B reports) to regulatory authorities as required.
• Register and maintain product legal labeling, including electronic Package Insert (ePI) and Unique Device Identification (UDI), in Japanese regulatory authority databases (MHLW and PMDA).
• Coordinate with global Quality Assurance and Vigilance teams to ensure alignment in PMS reporting and processes.
• Conduct GVP annual training and self-inspection to remain compliant with QMS and GVP ordinances as a Marketing Authorization Holder (MAH) in Japan.
• Manage suppliers related to GVP operations (e.g., case processing, translation services).
• Maintain documentation required for QMS and GVP compliance, including SOPs and audit readiness materials.
• Support QMS and GVP-related audits and inspections.
• Identify and support implementation of QMS and PMS process improvements.

Location: Tokyo, Japan

Must-haves

• BS in a related scientific field or equivalent.
• Minimum 5 years of experience in Vigilance or Quality Assurance in Pharma, IVD, or Medical Device industry.
• Experience in GVP and PMS activities in Japan.
• Experience interacting with MHLW, PMDA, or relevant regulatory authorities in vigilance and PMS areas.
• Ability to work in a matrix and global environment.
• Experience and knowledge of the database of Japanese regulatory authorities (MHLW and PMDA).
• Strong organizational skills and attention to detail.
• Ability to work independently as well as in a team environment.
• Proficient in Microsoft Office (Word, Outlook, Excel, PowerPoint).
• Fluent in Japanese and fluent in English.

Salary: Negotiable