Associate Director, Safety Operations, Japan
The Opportunity:
The Associate Director, Safety Operations , Japan is responsible for providing safety related operational expertise to safety management in Japan. The individual will be responsible for ensuring the timely, accurate, and compliant processing and management of safety information collection and reporting in collaboration with Global Patient Safety Operation team and other internal stakeholders, CROs, and other external partners.
Key Responsibilities:
ICSR and Safety Reporting Operations: Coordinate and review ICSR processing, follow-up, case quality review, expedited reporting, ensuring timely and compliant execution.
Safety Data Quality and Reconciliation: Review safety data quality and reconciliation activities, identify discrepancies or data quality issues, and coordinate appropriate follow-up and resolution.
Aggregate Reporting: Coordinate and review periodic and aggregate safety reports in Japan, ensuring completeness, consistency, quality, and compliance with applicable requirements.
Safety Agreements and Information Exchange: Coordinate the implementation and operational management of Safety Agreements and Pharmacovigilance Agreements (PVAs), including safety information exchange, agreed responsibilities, and reporting timelines.
Japan Pharmacovigilance Operations: Coordinate and review Japan-specific pharmacovigilance operations in accordance with applicable GVP/GPSP requirements and local procedures, including post-marketing safety activities such as EPPV and RMP-related risk minimization measures.
Compliance, Audit and Inspection Readiness: Coordinate self-inspections, internal audits, and regulatory inspections; identify and escalate operational and compliance issues; and follow up on CAPA implementation and issue resolution.
Vendor Oversight: Monitor and review the quality, completeness, accuracy, and timeliness of pharmacovigilance activities and deliverables performed by CROs and other external partners, and follow up on identified issues and corrective actions.
Process and Procedure Management: Develop and maintain Japan-specific pharmacovigilance procedures, work instructions, and operational workflows in alignment with applicable GVP/GPSP requirements, global processes, and local operational needs.
Training and Competency: Coordinate and support pharmacovigilance training for relevant employees and external partners, and maintain appropriate training records in accordance with applicable requirements.
Required Skills, Experience and Education:
Bachelor’s degree in a healthcare field.
Minimum of 7 years of relevant experience in pharmacovigilance/patient safety operational activities.
Hands-on experience working with CROs/vendors and management of external resources.
Strong background in safety reporting regulatory compliance and safety reporting/regulations both for clinical trials and post-marketing.
Comprehensive knowledge of Japanese safety-related regulations (GVP/GPSP) is required.
Ability to develop and maintain pharmacovigilance procedures, work instructions, and operational workflows in accordance with applicable requirements and global processes.
Ability to identify operational and compliance issues, assess their impact, prioritize actions, and coordinate timely resolution.
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:
Master’s Degree or higher in a healthcare field.
Experience establishing or improving pharmacovigilance processes, procedures, work instructions, and operational workflows in a developing organization.
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