Senior Manager, Patient Safety

Key Responsibilities

• Oversee Pharmacovigilance activities for marketed and development-stage products in Japan
  
• Act as a key backup to the Head of Patient Safety and support the deputy safety responsible role when required
  
• Ensure compliance with Japanese and global Pharmacovigilance requirements
  
• Manage external PV vendors and CROs, including case processing quality, database operations, contractual compliance, and regulatory reporting
  
• Maintain local PV processes, quality documents, and safety data exchange agreements
  
• Contribute to Japanese Risk Management Plans and risk minimization activities
  
• Support post-marketing safety activities, including EPPV and PMS, particularly for new product launches
  
• Support interactions with Japanese regulatory authorities, including inspections, self-inspections, and regulatory inquiries
  
• Collaborate with global Patient Safety teams on signal detection, benefit-risk assessment, aggregate reporting, and safety data exchange
  
• Work cross-functionally with Clinical Development, Regulatory Affairs, Medical Affairs, and Quality
  
• Contribute to safety sections of regulatory submissions and periodic safety reports
  
• Identify and implement improvements to Japan PV processes and systems
  

Key Activities

• Provide managerial oversight of end-to-end PV operations
  
• Review and provide quality oversight of ICSRs from post-marketing and clinical trial sources
  
• Prepare and review periodic safety reports and other required safety reports
  
• Maintain inspection readiness and support internal and external audits
  
• Oversee post-marketing safety programs and activities conducted with internal teams and external vendors
  
• Support safety planning and launch readiness for new products
  
• Monitor changes in Japanese PV regulations and regulatory expectations and implement necessary process improvements
  

Requirements

• Bachelor's degree or above in Pharmacy, Life Sciences, Nursing, Public Health, or a related field
  
• Extensive Pharmacovigilance experience within the pharmaceutical or biotechnology industry
  
• Strong knowledge of Japanese PV regulations and global Pharmacovigilance standards
  
• Experience with PMDA interactions and regulatory inspections
  
• Experience managing PV vendors/CROs and outsourced safety operations
  
• Experience with aggregate reporting, risk management plans, and safety-related regulatory submissions
  
• Experience with post-marketing safety activities and/or product launches is advantageous
  
• Previous experience as a deputy to a Japan safety responsible person is highly valued
  
• Strong communication skills in both Japanese and English
  

Benefits

Why Join

• Broader Safety Leadership: Opportunity to work closely with the Japan Patient Safety Head and develop toward a Deputy Safety Responsible role.
  
• Strategic Scope: Go beyond day-to-day PV operations and contribute to safety strategy, regulatory submissions, launch readiness, and risk management.
  
• Global Exposure: Collaborate closely with global Patient Safety teams and cross-functional stakeholders across the organization.
  
• Growing Portfolio: Gain exposure to both marketed products and pipeline assets approaching important regulatory milestones.
  
• High Visibility: Join a growing Japan organization where an experienced Patient Safety professional can have a meaningful impact on processes, compliance, and the development of the function.
  
• Opportunity to Drive Change: Take ownership of PV process improvement, vendor governance, and the continued development of Japan Patient Safety operations.