Director, Drug Safety & Pharmacovigilance - Japan

Location: Tokyo, Japan; hybrid work with the ability to work from home according to company guidelines. Occasional domestic and international travel is required, approximately 20%.

Company

hirify.global is a global biopharmaceutical company focused on transforming the lives of patients with serious and rare diseases.

What you will do

• Develop and maintain the local safety assurance system for commercial products in Japan.
• Oversee drug safety report collection, safety information assessment, regulatory reporting, and safety assurance measures.
• Maintain and control safety management documents, including the J-RMP and J-PSUR, and develop local SOPs and training.
• Support medical review, safety assessment, aggregate reporting, signal management, and risk management activities.
• Collaborate with Clinical Development, Medical Affairs, Regulatory Affairs, Medical Information, Quality Assurance, expert panels, and scientific contacts throughout development, J-NDA, and launch.
• Lead process improvements and build the talent pipeline through coaching, hiring, retention, and development.

Requirements

• Bachelor’s degree in healthcare or life science; a master’s degree is preferred.
• Excellent written and verbal communication and presentation skills in Japanese and English are required.
• At least eight years of drug safety or pharmacovigilance experience in the pharmaceutical industry, covering investigational and marketed products.
• Working knowledge of PMDA, ICH, CIOMS, GCP, clinical trial regulations, safety reporting, and ICSR processing.
• At least two years of experience with aggregate safety reporting, safety surveillance, signal management, or risk management.
• Experience with internal audits, regulatory inspections, people management, and resource or budget planning.

Nice to have

• Experience as a safety officer, in pharmacoepidemiology, or with scientific and regulatory document preparation.
• Experience preparing clinical safety assessments and regulatory submissions or presenting safety data to health authorities.
• Experience with Early Post-marketing Vigilance Studies, pharmacovigilance databases such as Argus, MedDRA, medical devices, or project management.

Culture & Benefits

• Flexible working hours and vacation programs supporting work-life balance.
• Retirement benefits, stock compensation, and access to the employee stock purchase plan.
• Internal and external training, LinkedIn Learning, specialized professional training, and AI-enabled learning tools.
• Hybrid-work technology and IT support enabling collaboration across locations and time zones.
• Global recognition programs and employee resource groups.