Director of Pharmacovigilance Quality and Alliance Management
Location: Boston or Remote
Job Summary
The Director of Pharmacovigilance Quality and Alliance Management will play a critical role in Aveo Oncology's Pharmacovigilance (PV) team, ensuring the highest standards of drug safety and compliance. This position involves overseeing the quality management of pharmacovigilance activities and managing strategic alliances with external partners. The Director will collaborate across clinical development, regulatory affairs, commercial teams, and external stakeholders to support the delivery of safe and effective oncology therapies.
Key Responsibilities
Pharmacovigilance Quality Management
Develop, implement, and maintain a comprehensive Pharmacovigilance Quality Management System (PV QMS) in compliance with global regulatory requirements (e.g., FDA, EMA, ICH).
Lead PV quality audits, including internal audits and assessments of external partners/vendors, ensuring adherence to SOPs and regulatory standards.
Oversee the preparation and execution of Corrective and Preventive Actions (CAPAs) following audits and inspections.
Monitor and analyze pharmacovigilance processes, identifying improvement areas and implementing necessary changes.
Serve as the primary contact for regulatory inspections related to pharmacovigilance and ensure audit readiness.
Alliance Management
Manage relationships with external partners, including contract research organizations (CROs) and pharmaceutical collaborators, involved in pharmacovigilance activities.
Negotiate and oversee agreements related to pharmacovigilance and quality responsibilities, ensuring alignment of expectations.
Monitor the performance of external partners to ensure compliance with contractual obligations and regulatory requirements.
Facilitate regular meetings with alliance partners to discuss performance, issues, and improvement opportunities.
Strategic Leadership
Provide strategic direction for the Pharmacovigilance Quality and Alliance Management functions.
Collaborate with senior leadership to align pharmacovigilance and quality initiatives with the company’s overall business strategy.
Represent Aveo Oncology in industry forums, conferences, and other external engagements related to pharmacovigilance and quality.
Team Development and Management
Lead and mentor a team of pharmacovigilance and quality professionals, fostering a culture of continuous improvement.
Ensure ongoing professional development of team members, providing training and career growth opportunities.
Allocate resources effectively to meet departmental and company goals.
Qualifications
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 in pharmacovigilance or drug safety.
Excellent leadership, communication, and negotiation skills.
Ability to thrive in a fast-paced, dynamic environment with cross-functional teams.
Strong analytical and problem-solving abilities.
About AVEO
AVEO is a commercial-stage biopharmaceutical company focused on oncology, committed to delivering medicines that improve the lives of cancer patients. We currently market FOTIVDA® (tivozanib) in the U.S. for treating adult patients with relapsed or refractory renal cell carcinoma (RCC). AVEO continues to develop FOTIVDA in immuno-oncology combinations and has several investigational programs in clinical development. We are dedicated to fostering a diverse, equitable, and inclusive workplace.
Equal Opportunity Employment All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.
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