Senior Manager PV Audits Professional
Vor 3 Tagen
Daiichi Sankyo Europe: A Leader in Pharmacovigilance Audits
At Daiichi Sankyo Europe, we are seeking a highly skilled and experienced Senior Manager PV Audits to support our Pharmacovigilance audits and regulatory inspections.
Key Responsibilities:
- Plan, schedule, conduct, and report Pharmacovigilance audits to ensure compliance with regulatory requirements
- Document audit findings, CAPA, and tracking of CAPA commitment implementation
- Support regulatory inspections, preparing responses, evaluating supporting documentation, and tracking CAPA implementation
- Evaluate and escalate critical findings from audits and inspections
- Ensure Quality Assurance SOPs and policies are current and compliant with laws, regulations, and Daiichi-Sankyo standards
- Support quality documentation and system implementation programs
- Liaise with CSPV and others to ensure local and global compliance with regulatory requirements and internal standards
Requirements:
- Bachelor's Degree in a scientific, health care, or related discipline, or a background in Medical health Profession
- At least 7 years of Quality Assurance experience in the Pharmaceutical/CRO industry
- First-hand knowledge of GVP Compliance, Oncology, Specialty Medicines, and Companion Diagnostic products
- Experience working with Health Authorities, such as FDA, HPFB, MHRA, and other European regulatory agencies
- International experience is a plus, with experience working with diverse cultures and employees
Daiichi Sankyo Europe is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law.
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