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Director of Pharmacovigilance and Quality Assurance
hace 1 mes
At AVEO, we are seeking a highly skilled Director of Pharmacovigilance and Quality Assurance to join our team. As a key member of our Pharmacovigilance team, you will be responsible for ensuring the highest standards of drug safety and compliance within our organization.
Key Responsibilities:- Develop and implement a comprehensive Pharmacovigilance Quality Management System (PV QMS) to ensure compliance with global regulatory requirements.
- Lead PV quality audits, including internal audits and audits of external partners/vendors, to ensure adherence to SOPs, regulatory requirements, and best practices.
- Oversee the preparation and execution of Corrective and Preventive Actions (CAPAs) following PV audits and inspections.
- Monitor and analyze pharmacovigilance processes, identifying areas for improvement and implementing necessary changes.
- Manage relationships with external partners, including contract research organizations (CROs), pharmaceutical partners, and other vendors involved in pharmacovigilance activities.
- Negotiate and oversee agreements related to pharmacovigilance and quality responsibilities, ensuring clear communication and alignment of expectations.
- Advanced degree in a scientific discipline is preferred.
- Minimum of 10 years of experience in pharmacovigilance, quality management, or a related field within the pharmaceutical or biotechnology industry.
- In-depth knowledge of global pharmacovigilance regulations, guidelines, and best practices.
- Proven experience in managing quality systems, conducting audits, and leading regulatory inspections.
- Strong alliance management experience, particularly in the context of pharmacovigilance or drug safety.
AVEO is a commercial-stage, oncology-focused biopharmaceutical company committed to delivering medicines that provide a better life for patients with cancer. We are dedicated to creating an environment of diversity, equity, and inclusion to diversify representation within the Company.
