Director of Global Pharmacovigilance Quality Assurance
1 month ago
At Kyowa Kirin International, we are committed to making a difference in the lives of our patients and their families. 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 supporting 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 for affiliates, partners, vendors, and processes.
- Select and manage qualified service providers for GQA, including contract auditors.
- 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.
- Expert knowledge and experience in relevant regulations and guidance documents, including Pharmacovigilance, Clinical Development, Medical Device, IMP management, Regulatory Affairs, and Pharmacovigilance.
Kyowa Kirin International is an equal opportunities employer. If you require any additional support through the interview process, please do not hesitate to contact us in complete confidence.
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