Senior Manager PV Audits Lead
vor 4 Wochen
About Daiichi Sankyo Europe
Daiichi Sankyo Europe is a leading pharmaceutical company dedicated to discovering, developing, and delivering innovative treatments that improve patients' lives.
Job Title: Senior Manager PV Audits
We are seeking a highly skilled and experienced Senior Manager PV Audits to join our team in Munich, Germany. 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, including service providers, systems, and processes, to ensure compliance with regulatory requirements.
- Document audit findings, CAPA implementation, and tracking/verification of CAPA commitment in electronic quality management systems.
- Support pharmacovigilance regulatory inspections, including preparation, conduct, coordinating responses, and evaluating supporting documentation.
- Evaluate and escalate critical findings from audits and inspections to QA and functional department leadership.
- Support the management of Quality Assurance SOPs and policies to ensure they are current, compliant with laws, regulations, and Daiichi-Sankyo standards.
- Liaise and consult with CSPV and others to ensure local and global conformance with regulatory requirements, GvP, internal standards, and to provide proactive integration of quality and process improvement.
Requirements:
- Bachelor's Degree in a scientific, healthcare, or related discipline and/or background in Medical health Profession (RN, Medical technologist, etc.) required.
- 7 or more years of Quality Assurance experience with a world-class quality organization in the Pharmaceutical/CRO industry.
- 7 or more years of First-hand knowledge of GVP Compliance Professional or other related function and familiarity with Oncology, Specialty Medicines, and Companion Diagnostic products.
- 7 or more years of Experience of direct dealings with Health Authorities (e.g., FDA, HPFB, MHRA, and other European regulatory agencies).
- 7 or more years of International experience is a plus; but at minimum, experiences working with diverse cultures and employees.
Why work with us?
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 and challenging 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 eagerly await your application.
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