PV Compliance Expert
vor 3 Wochen
Daiichi Sankyo Europe is a global pharmaceutical company with over 120 years of experience, employing more than 17,000 employees in over 20 countries. We are dedicated to discovering, developing, and delivering new standards of care that enrich the quality of life around the world.
Estimated Salary: €80,000 - €110,000 per yearWe are seeking a highly skilled Senior Manager PV Audits to join our team in Munich, Germany. The successful candidate will be responsible for supporting all aspects of pharmacovigilance audits and regulatory inspections, ensuring compliance with GVP regulations and internal standards.
Job DescriptionThe Senior Manager, GvP Audits will report to the Head of Global Audits and Compliance and will be responsible for:
- Planning, scheduling, conducting, and reporting pharmacovigilance audits, including Service Providers, systems, and processes, license partners, and affiliates;
- Documenting audit conduct, findings, CAPA, and tracking/verification of CAPA commitment implementation within the electronic quality management system;
- Supporting all aspects of pharmacovigilance regulatory inspections, including preparation, conduct, coordinating responses, evaluating supporting documentation, tracking, and verification of CAPA commitment implementation and effectiveness checks;
- Escalating critical findings from audits and inspections to QA and functional department leadership;
- Supporting the management of Quality Assurance SOPs and policies to ensure they are current, adhere to laws, regulations, guidance documents, and Daiichi-Sankyo standards;
- Supporting quality documentation and quality system implementation programs;
- Liaising and consulting with CSPV and others to ensure local and global conformance with regulatory requirements, GvP, internal standards, and providing proactive integration of quality and process improvement.
To be successful in this role, you will need:
- A Bachelor's Degree in a scientific, healthcare, or related discipline and/or background in medical health profession (RN, Medical technologist, etc.);
- At least 7 years of Quality Assurance experience with a world-class quality organization in the Pharmaceutical/CRO industry;
- First-hand knowledge of GVP Compliance Professional or other related function and familiarity with Oncology, Specialty Medicines, and Companion Diagnostic products;
- Experience of direct dealings with Health Authorities (e.g., FDA, HPFB, MHRA, and other European regulatory agencies);
- International experience is a plus, but at minimum, experiences working with diverse cultures and employees.
Daiichi Sankyo Europe is an equal opportunity/affirmative action employer. We foster a culture of mutual respect and continuous learning, with a strong commitment to inclusion and diversity. Here, you will have the opportunity to 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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