Senior Manager, Global Patient Safety

Position Overview

Our mission is to safeguard patient safety and lead pharmacovigilance (PV) in Japan.

The Senior Manager, Global Patient Safety (GPS) reports to the Director, GPS (Safety Management Officer) in Japan and serves as a core leader for safety operations, overseeing the handling of Individual Case Safety Reports (ICSR), Investigation Reports (RR), and Foreign Measures Taken (FSMT) reports. Additionally, this role proactively drives aggregate reporting, vendor management, and GVP-related activities to ensure both quality and compliance.

What Makes This Role Attractive

• Make meaningful impact in a high-stakes safety function as a key member driving Japan’s PV framework
• Lead vendors and cross-functional teams to design and implement process improvements
• Contribute to pivotal documents directly linked to development and post-approval, including J-RMP and J-NDA
• Collaborate globally and gain experience bridging international standards with Japanese regulations
• Build your career through audits and inspections exposure and by managing complex, high-impact projects

Responsibilities

• Serve as Japan’s point of contact for ICSR, RR, and FSMT handling, ensuring quality and on-time delivery
• Lead local aggregate reporting and ensure submissions meet regulatory requirements
• Monitor and oversee PV service providers, ensuring performance aligns with contracts and project plans
• Review provider-prepared assessments and PMDA reports for accuracy and execute improvement actions
• Design and drive continuous process improvements to enhance quality and compliance
• Lead creation and revision of SOPs and plan/execute related training as needed
• Contribute to Japan Risk Management Plan (J-RMP) development and manage planning, execution, and tracking
• Partner effectively with internal cross-functional teams (Medical Affairs, Regulatory Affairs, Commercial/Marketing, Clinical Development) and license partners to ensure the quality and alignment of PV deliverables
• Contribute to the safety section of the Japan New Drug Application (J-NDA) and lead resolution of PMDA inquiries

Qualifications

• 7+ years of hands-on experience in drug safety/pharmacovigilance within the pharma/biotech industry
• Strong knowledge of PMDA/MHLW/ICH guidelines and regulations governing PV in both clinical trials and post-marketing settings
• Proven track record of delivering results through cross-functional collaboration with Medical Affairs, Regulatory Affairs, Commercial, and Clinical Development
• Experience supporting or leading regulatory authority audits/inspections, including PMDA re-examination, MAH license renewal, and GCP reliability inspections
• Project management experience in complex initiatives such as safety database implementations, function/team improvements, and transfers of business authorizations (including safety data migration)
• Experience in contracting and managing external service providers
• Practical experience in global PV

Career Opportunities

• Gain a panoramic view of Japan’s safety operations and participate in high-impact decision-making
• Strengthen both subject-matter expertise and leadership capabilities through global collaboration and Japanese regulatory engagement
• Build a resilient career through deep involvement in key deliverables such as SOPs, J-RMP, and J-NDA