Safety Officer (Pharmacovigilance)

TL;DR

Safety Officer (Pharmacovigilance, Japan): Develop and maintain local safety assurance systems for commercial and investigational products with an accent on compliance with PMDA regulations, timely reporting, and risk management. Focus on leading safety processes, conducting audits, signal detection, and cross-functional collaboration for product launches.

Head Office in Tokyo - You may work from home according to company guidelines. Occasional domestic/international travel (approx. 20%).

Company

Global biopharmaceutical company dedicated to transforming lives of patients with serious and rare diseases.

What you will do

• Develop and maintain local safety assurance system for safe product use, including collection, examination, and reporting of safety information to authorities.
• Conduct self-inspections, support internal/external audits, and implement safety measures.
• Contribute to J-RMP, J-PSUR, local SOPs, and training; monitor GVP regulation changes.
• Collaborate cross-functionally on investigational products from development to launch with Clinical, Medical Affairs, Regulatory, and QA.
• Lead medical safety reviews, signal detection, aggregate analyses, and process improvements.
• Enhance team capabilities through training, coaching, and talent development.

Requirements

• Excellent communication and presentation skills in Japanese and English.
• Bachelor’s in health care/life science (Master’s preferred).
• Minimum 8 years in drug safety/pharmacovigilance with investigational and marketed products; knowledge of PMDA, ICH, GCP.
• Experience with ICSR management, aggregate reporting, safety surveillance, signal/risk management.
• Participation in audits/inspections; people management, resource/budget planning.

Nice to have

• 2+ years as safety officer; pharmacoepidemiology knowledge.
• Experience preparing regulatory/safety documents, presenting to authorities, leading post-marketing studies.
• Knowledge of Argus, MedDRA; device experience; project management.

Culture & Benefits

• Hybrid work environment with flexible hours and comprehensive vacation policy.
• Attractive compensation: retirement plans, stock rewards, ESPP.
• Career development: internal/external training, LinkedIn Learning, AI learning tools.
• Global recognition programs, employee resource groups.
• Modern Tokyo office promoting collaboration and work-life balance.