Associate Director - Safety Systems

The Opportunity:

The Associate Director, Safety Systems, Japan is responsible for providing safety and pharmacovigilance systems expertise to support safety management activities in Japan. The individual will be responsible for ensuring the effective operation and local use of global safety databases and related pharmacovigilance systems, coordinating Japan-specific system requirements and changes, and ensuring appropriate system administration, data quality, documentation, and user support in accordance with applicable Japanese regulations such as GVP/GPSP, company procedures, and global pharmacovigilance/patient safety standards.

The Associate Director, Safety Systems works closely with Global Safety Systems, Global IT, and other Global/Japan Safety Functions and  cross-functional stakeholders to ensure the reliable, compliant, and effective use of safety systems in Japan. The individual also coordinates with CROs, system vendors, and other external partners, supporting system issue resolution, validation and change activities, audit and inspection readiness, and continuous improvement of local safety system operations.

Key Responsibilities:

• Safety System Operations and Global Coordination: Coordinate with Global Safety Systems and relevant global functions to ensure the effective use of global safety databases and related pharmacovigilance systems in Japan.

• Local System Administration and User Access: Manage Japan-specific system administration activities, including user access, user roles, local workflows, and other administrative tasks in accordance with approved procedures and global standards.

• System Data Quality and Controls: Monitor system data integrity and system controls for Japan operations; identify discrepancies or system-related issues and coordinate appropriate investigation and resolution.

• Local Requirements and System Changes: Coordinate Japan-specific business and regulatory requirements for system changes, enhancements, releases, and configuration updates with Global Safety Systems and relevant stakeholders.

• System Validation and Compliance: Support system validation, periodic reviews, change control, and related compliance activities in accordance with applicable GVP/GPSP requirements, global procedures, and computer system validation principles.

• System Issue and Incident Management: Coordinate the investigation, documentation, escalation, and resolution of system incidents, defects, and operational issues affecting Japan operations.

• Vendor and System Provider Oversight: Monitor and review system support and deliverables provided by system vendors, CROs, and other external service providers, and follow up on identified issues and agreed actions.

• Process and Documentation Management: Develop and maintain Japan-specific safety system procedures, work instructions, and operational documentation in alignment with global processes and applicable local requirements.

• Training and User Support: Coordinate and support system-related training, user guidance, and ongoing support for Japan users and relevant external partners.

• Audit and Inspection Readiness: Support audits and regulatory inspections by ensuring the availability, completeness, and consistency of Japan-specific system documentation, records, and validation evidence.

Required Skills, Experience and Education:

• Bachelor’s degree in a scientific, technical, or related field is required

• At least 7 years of experience in pharmacovigilance systems, safety operations, or related technical domains

• Experience supporting system changes, releases, enhancements, incidents, defects, or other system-related operational issues.

• Solid knowledge of safety databases and related pharmacovigilance systems, including system workflows, user access, data controls, and system operations.

• Understanding of pharmacovigilance processes and applicable Japan GVP/GPSP requirements, particularly system-related requirements.

• Strong collaboration and communication skills, with the ability to work effectively with internal stakeholders, global safety teams, CROs, and other external partners.

• Strong learning orientation, curiosity, and commitment to science and patients.

• Business-level English and native-level Japanese proficiency.

• Experience within a global and multicultural environment.

Preferred Skills:

• Advanced degree is preferred

• Hands‑on expertise with safety databases and analytics platforms (e.g., Safety One Argus, Empirica Signal, Spotfire, Oracle Analytics Server)

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