Senior Manager PV Audits Lead
vor 2 Monaten
We are seeking a highly skilled Senior Manager PV Audits to join our team at Daiichi Sankyo Europe. As a key member of our Pharmacovigilance department, you will be responsible for supporting all aspects of pharmacovigilance audits and regulatory inspections.
Key Responsibilities- Plan, schedule, conduct, and report pharmacovigilance audits to ensure compliance with regulatory requirements.
- Document audit findings, CAPA implementation, and tracking of CAPA commitments within our electronic quality management systems.
- Support pharmacovigilance regulatory inspections, including preparation, conduct, and evaluation of supporting documentation.
- Evaluate and escalate critical findings from audits and inspections to QA and functional department leadership.
- Contribute to the development and maintenance of Quality Assurance SOPs and policies.
- Bachelor's degree in a scientific, healthcare, or related discipline.
- At least 7 years of quality assurance experience in the pharmaceutical or CRO industry.
- First-hand knowledge of GVP compliance and experience with oncology, specialty medicines, and companion diagnostic products.
- Experience working with health authorities, such as the FDA, HPFB, and MHRA.
At Daiichi Sankyo Europe, we foster a culture of mutual respect and continuous learning, with a strong commitment to inclusion and diversity. We offer a dynamic work environment where you can grow, think boldly, and contribute your ideas. If you have a proactive mindset and passion for addressing the needs of patients, we encourage you to apply.
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Senior Manager PV Audits Lead
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