PMS Planning & Management Head (Pharmaceutical Safety)

Location: Tokyo, Japan

Company

hirify.global is an R&D-driven, AI-powered biopharma company developing medicines and vaccines focused on the immune system.

What you will do

• Lead and develop a high-performing post-marketing surveillance team.
• Design and oversee PMS programs, including usage surveys, database studies, and post-marketing clinical trials.
• Lead engagement and negotiations with Japanese regulatory authorities, including inquiries, consultations, and re-examination application conformity inspections.
• Oversee study outlines, protocols, case report forms, global approvals, analysis plans, clinical study reports, and periodic safety reporting.
• Coordinate PMS execution with Development, Medical, Safety, Regulatory Affairs, Commercial, and global stakeholders.
• Mentor team members and modernize PMS processes in response to evolving regulations.

Requirements

• At least 5 years of experience in post-marketing surveillance and investigations, including end-to-end programs across multiple products or therapeutic areas.
• Experience planning and conducting post-marketing database studies.
• Knowledge of Japan’s Pharmaceutical and Medical Device Act and GPSP, or hands-on experience in a GxP-regulated environment.
• Experience preparing regulatory documents, study protocols, analysis plans, and scientific reports.
• Strong stakeholder communication, strategic decision-making, project leadership, and task management skills.
• Business-level English communication skills and fluent Japanese are required.

Culture & Benefits

• Leadership opportunities with direct impact on patient safety and the Japan medicines portfolio.
• Cross-functional and international collaboration with global teams and leaders.
• Opportunities to modernize regulatory commitment management and introduce new approaches.
• Stretch leadership opportunities, cross-functional exposure, and development programs.
• Inclusive, collaborative, high-performing work environment.
• Flexible working options, comprehensive healthcare, and 14 weeks of gender-neutral parental leave.