Position: Medical and Safety Manager
Location: Tokyo, Japan (Hybrid Work Arrangement)
Overview
We are looking for a Patient Safety & Medical Manager to join the Medical and Regulatory Affairs team in Japan. Reporting directly to the Country Lead, this role will act as the designated Anseki for Japan, with responsibility for Patient Safety, Pharmacovigilance, and Medical Affairs.
The role is central to ensuring compliance with post-marketing safety regulations while supporting commercial objectives through medical governance and scientific engagement. This position plays a critical role in protecting patients, maintaining regulatory standards, and contributing to business growth with trusted medical expertise.
Key Responsibilities
Patient Safety & Pharmacovigilance (Anseki)
Establish and maintain a compliant post-marketing safety system (GVP) in Japan.
Oversee safety monitoring, reporting, and risk management in line with PMDA requirements.
Manage collection, review, and submission of safety data from both domestic and international sources.
Supervise SOPs, audits, inspections, training, and regulatory documentation (e.g., J-RMP, package inserts).
Ensure inspection readiness and coordinate with global safety teams on regulatory responses.
Medical Affairs
Provide accurate and timely medical information to internal teams and external stakeholders.
Review promotional and marketing materials to ensure compliance with regulations and industry codes.
Monitor, analyze, and distribute relevant medical literature to support brand claims and product positioning.
Collaborate with Commercial, Regional, and Global teams on product development, claims, and innovation strategies.
Deliver medical expertise for scientific events, symposia, and competitor intelligence.
Other Responsibilities
Participate in global, regional, and local projects within Medical and Regulatory Affairs as required.
Qualifications & Skills
Bachelor’s degree with a pharmacist license (required).
10–15 years of experience in Pharmacovigilance and/or Medical Affairs.
In-depth knowledge of Japanese GVP regulations, international safety standards, and therapeutic areas.
Ability to interpret clinical data, review promotional content, and ensure compliance in medical communications.
Strong leadership, organizational, and decision-making skills.
Excellent communication and collaboration abilities, including stakeholder management and engagement with KOLs.
Personal Attributes
Proactive, team-oriented, and detail-focused.
Strong multitasking, prioritization, and planning skills.
Proficiency in Microsoft Office; adaptable and eager to learn with a positive mindset.