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About the Role
This role offers a unique opportunity to lead Pharmacovigilance activities for marketed and development-stage products in Japan. You will act as a key backup to the Head of Patient Safety and support the deputy safety responsible role, ensuring compliance with Japanese and global PV requirements. The position involves managing external vendors, maintaining local PV processes, contributing to risk management plans, and collaborating with global teams and cross-functional stakeholders.
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
- 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
Education Level
- Bachelor's degree or above in Pharmacy, Life Sciences, Nursing, Public Health, or a related field
Benefits
- 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.