Senior Manager, Global Patient Safety (Pharmacovigilance)

Location: Japan, Minato City; hybrid work model

Company

hirify.global is a biotechnology company that invents, develops, and commercializes medicines for serious diseases.

What you will do

• Serve as the primary contact for Japan ICSR, research report, and FSMT activities.
• Review vendor-prepared safety evaluations and PMDA submissions for accuracy.
• Oversee pharmacovigilance service providers and monitor contract compliance.
• Drive process improvements, author working instructions, and deliver related training.
• Contribute to J-RMP development and execution activities.
• Collaborate with external departments, license partners, and cross-functional teams on safety deliverables.

Requirements

• More than 7 years of pharmacovigilance and post-marketing surveillance operations experience.
• Strong knowledge of PMDA, MHLW, and International Council for Harmonisation guidelines and regulations.
• Experience with Japan aggregate reporting, local pharmacovigilance activities, J-NDA safety content, and responses to PMDA inquiries.
• Experience managing external service providers and vendor relationships.
• Experience with regulatory inspections, including PMDA re-examination, MAH license renewal, or GCP reliability inspection.
• Experience leading complex projects such as team improvement, safety database implementation, or safety data migration initiatives.

Culture & Benefits

• Science-driven organization focused on developing life-changing medicines.
• Inclusive workplace and equal opportunity employment.
• Comprehensive rewards may include bonuses, equity awards, retirement benefits, insurance, paid time off, and family support benefits.
• Background checks may be conducted in accordance with the laws of the country where the position is based.