Manager, Case Management – Local Medical Safety

About the role

Johnson & Johnson is seeking a Manager to lead its Case Management Group in Japan. The role oversees operational management, ensures compliance with safety reporting regulations, and drives continuous improvement of case processing efficiency.

Key responsibilities

• Lead operational management of the Case Management Group, ensuring high‑quality, timely case processing and optimal resource utilization.
• Maintain compliance with PMDA, Global Medical Safety and Local Medical Safety reporting timelines, escalating risks as needed.
• Monitor and improve the quality of adverse event reporting, implementing risk‑based improvements and outsourcing where appropriate.
• Handle internal audits and external inspections, conducting root‑cause analyses and proposing corrective actions.
• Communicate effectively with LMS Japan, GMS, and other stakeholders, providing subject‑matter expertise and alignment on case processing.

Required profile

• Minimum 6 years of pharmaceutical industry experience in safety‑related areas, including individual case processing and aggregate reporting.
• Experience working in a cross‑cultural or global environment.
• Strong knowledge of international safety reporting regulations and compliance requirements.
• Demonstrated leadership skills with the ability to coach and develop junior staff.
• Fluent English (TOEIC 800+ preferred) and proficiency in medical terminology.

Required skills

• Pharmacovigilance and safety reporting
• Regulatory compliance (PMDA, global safety)
• Medical terminology proficiency
• Microsoft Word, Excel, PowerPoint
• Safety‑reporting systems