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Director of Global Pharmacovigilance Quality Assurance
2 months ago
At Kyowa Kirin International, we are committed to making a difference in the lives of those who need it most. As a Director of Global Pharmacovigilance Quality Assurance, you will play a critical role in ensuring the quality and integrity of our pharmacovigilance processes.
Key Responsibilities:- Develop and execute the Global Pharmacovigilance Audit Strategy and Schedule in collaboration with the Global Head of GxP Inspections & GVP Quality.
- Maintain risk standards and methodologies, audit methodology, and best practices to ensure consistency of approach.
- Support the continuous improvement of Kyowa Kirin's Quality System, including PV inspections, regulatory intelligence activities, SOP and WI management, and project liaison activities.
- Lead the annual risk assessment and manage the audit plan for global and regional GVP entities.
- Conduct and manage audits, including contract auditors, in line with the audit plan, Kyowa Kirin's business model, and applicable procedures.
- Strong knowledge and experience of PV/Quality/Regulatory Authority, including Quality Management for Pharmacovigilance.
- Qualification and experience as an auditor.
- Line management experience.
- Expert knowledge and experience in Pharmacovigilance Audits, Pharmacovigilance, and/or Quality Assurance.
- Degree in natural science or equivalent number of years' experience.
Kyowa Kirin International is an equal opportunities employer. We offer a dynamic and inclusive work environment, opportunities for professional growth and development, and a competitive compensation package.
