Director of Pharmacovigilance Quality Management

3 days ago


Étreux, Hauts-de-France, United States Page Mechanical Group Inc Full time

Job Summary

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The Director of Pharmacovigilance Quality will oversee the quality management of pharmacovigilance activities, ensuring compliance with global regulatory requirements. This role involves developing and implementing a comprehensive Pharmacovigilance Quality Management System (PV QMS) and leading PV quality audits.

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About the Role

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We are seeking an experienced professional to lead our Pharmacovigilance Quality team. The ideal candidate will have in-depth knowledge of global pharmacovigilance regulations, guidelines, and best practices. They should have proven experience in managing quality systems, conducting audits, and leading regulatory inspections.

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Key Responsibilities

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  • Develop and implement a comprehensive PV QMS to ensure compliance with global regulatory requirements">
  • Lead PV quality audits, including internal audits and audits of external partners/vendors">
  • 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">
  • Serve as the key point of contact for regulatory inspections related to pharmacovigilance and ensure audit readiness">
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Requirements

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Minimum 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.

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Estimated Salary: $120,000 - $150,000 per year

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This is a full-time position based in Boston or remote. We offer a competitive salary, excellent benefits package, and opportunities for professional growth and development.



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