Associate Director, PV Systems and Vendor Management, Local Medical Safety

About the role

The Associate Director, PV Systems and Vendor Management will lead the strategy, governance and operational excellence of pharmacovigilance (PV) systems and vendor activities for Johnson & Johnson Innovative Medicine in Japan. Reporting to the Country Safety Head, the role ensures compliance with global standards and Japanese regulations while driving efficiency and audit readiness.

Key responsibilities

• Lead governance and lifecycle management of PV systems, ensuring validation, upgrades and change control align with global safety standards.
• Oversee vendor selection, onboarding, performance monitoring and issue resolution for case processing and literature screening.
• Develop and optimise workflows, incorporating AI and automation tools to improve PV efficiency and data integrity.
• Manage outsourcing budget, resource planning and strategic outsourcing initiatives.
• Support regulatory inspections, internal audits and lead CAPA implementation related to systems or vendor quality issues.

Required profile

• Advanced degree (BSc, MSc or equivalent) in a biological or medical field.
• 5‑8 years of pharmacovigilance experience, including at least 2 years in case management.
• Minimum 3 years of direct team management experience.
• Strong knowledge of GVP, GCP, ICH guidelines and Japanese Pharmaceuticals and Medical Devices Act.
• Fluent written and spoken Japanese and business‑level English.

Required skills

• Experience with PV systems such as Argus, ArisG and LSMV.
• Vendor management and performance monitoring.
• Familiarity with digital/automation tools (RPA, AI) in PV.
• Project management for system implementation or transformation.