Senior Pharmacovigilance Quality and Alliance Director
7 days ago
Job Title: Senior Pharmacovigilance Quality and Alliance Director
Estimated Salary: $150,000 - $180,000 per year
About the JobWe are seeking a highly skilled and experienced Senior Pharmacovigilance Quality and Alliance Director to join our team at Page Mechanical Group Inc. in Boston or remotely.
This is an exciting opportunity for a seasoned professional with a passion for pharmacovigilance, quality management, and strategic alliances.
Key Responsibilities:- Develop and implement comprehensive pharmacovigilance quality management systems to ensure compliance with global regulatory requirements.
- Lead 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 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.
- Manage relationships with external partners, including contract research organizations (CROs), pharmaceutical partners, and other vendors involved in pharmacovigilance activities.
- Advanced degree in a scientific discipline 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.
- Excellent leadership, communication, and negotiation skills.
- Ability to work effectively in a fast-paced, dynamic environment with cross-functional teams.
- Strong analytical and problem-solving abilities.
Page Mechanical Group Inc 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.
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