Pharmacovigilance Manager (Japan)

Location: Must be based in Tokyo, Japan (Hybrid work available)

Company

hirify.global is a global biopharmaceutical company dedicated to transforming the lives of patients with serious and rare diseases, recognized as a top employer and a great place to work.

What you will do

• Develop and maintain a local safety assurance system to support the safe use of commercial products.
• Manage drug safety reports, ensure timely reporting to competent authorities, and implement safety assurance measures.
• Control safety management documentation, including J-RMP and J-PSUR.
• Collaborate with cross-functional teams including Clinical Development, Medical Affairs, and Regulatory Affairs.
• Lead process improvements and ensure compliance with local GVP regulations.
• Attract, retain, and develop talent within the PV organization.

Requirements

• Bachelor’s degree in health care or life science required (Master’s preferred).
• Minimum 8 years of experience in Drug Safety/Pharmacovigilance in the pharmaceutical industry.
• Fluent in both Japanese and English (verbal and written).
• Working knowledge of PMDA, ICH guidelines, GCP, and GVP regulations.
• At least 2 years of experience in aggregate safety reporting, signal management, and risk management.
• People management and resource/budget planning experience.

Culture & Benefits

• Flexible working hours and comprehensive leave policies.
• Attractive compensation including retirement benefits, stock options, and employee stock purchase plans.
• Extensive career development support including internal/external training and LinkedIn Learning.
• Hybrid work environment with modern IT support.
• Global recognition programs and employee resource groups.