Page Mechanical Group, Inc.
Director of Pharmacovigilance Quality and Alliance Management
Page Mechanical Group, Inc., Boston, Massachusetts, us, 02298
JOB TITLE: Director of Pharmacovigilance Quality and Alliance Management
LOCATION: Boston or Remote
JOB SUMMARY:
The Director of Pharmacovigilance Quality and Alliance Management will be a pivotal member of the Pharmacovigilance (PV) team, responsible for ensuring the highest standards of drug safety and compliance within Aveo Oncology. This role involves overseeing the quality management of pharmacovigilance activities and managing strategic alliances with external partners. The Director will collaborate cross-functionally with clinical development, regulatory affairs, commercial teams, and external stakeholders to support the delivery of safe and effective oncology therapies.
Pharmacovigilance Quality Management:
Develop, implement, and maintain a comprehensive Pharmacovigilance Quality Management System (PV QMS) to ensure compliance with global regulatory requirements (e.g., FDA, EMA, ICH).
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.
Serve as the key point of contact for regulatory inspections related to pharmacovigilance and ensure audit readiness.
Alliance Management:
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.
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 opportunities for improvement.
Strategic Leadership:
Provide leadership and 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 and excellence.
Ensure the ongoing professional development of team members, providing opportunities for training and career growth.
Allocate resources effectively to meet departmental and company goals.
PRINCIPAL DUTIES:
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.
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.
About AVEO:
AVEO is a commercial-stage, oncology-focused biopharmaceutical company committed to delivering medicines that provide a better life for patients with cancer. AVEO currently markets FOTIVDA (tivozanib) in the U.S. for the treatment of adult patients with relapsed or refractory renal cell carcinoma (RCC) following two or more prior systemic therapies. AVEO continues to develop FOTIVDA in immuno-oncology combinations in RCC and other indications, and has several other investigational programs in clinical development. AVEO is committed to creating an environment of diversity, equity and inclusion to diversify representation within the Company.
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.
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LOCATION: Boston or Remote
JOB SUMMARY:
The Director of Pharmacovigilance Quality and Alliance Management will be a pivotal member of the Pharmacovigilance (PV) team, responsible for ensuring the highest standards of drug safety and compliance within Aveo Oncology. This role involves overseeing the quality management of pharmacovigilance activities and managing strategic alliances with external partners. The Director will collaborate cross-functionally with clinical development, regulatory affairs, commercial teams, and external stakeholders to support the delivery of safe and effective oncology therapies.
Pharmacovigilance Quality Management:
Develop, implement, and maintain a comprehensive Pharmacovigilance Quality Management System (PV QMS) to ensure compliance with global regulatory requirements (e.g., FDA, EMA, ICH).
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.
Serve as the key point of contact for regulatory inspections related to pharmacovigilance and ensure audit readiness.
Alliance Management:
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.
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 opportunities for improvement.
Strategic Leadership:
Provide leadership and 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 and excellence.
Ensure the ongoing professional development of team members, providing opportunities for training and career growth.
Allocate resources effectively to meet departmental and company goals.
PRINCIPAL DUTIES:
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.
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.
About AVEO:
AVEO is a commercial-stage, oncology-focused biopharmaceutical company committed to delivering medicines that provide a better life for patients with cancer. AVEO currently markets FOTIVDA (tivozanib) in the U.S. for the treatment of adult patients with relapsed or refractory renal cell carcinoma (RCC) following two or more prior systemic therapies. AVEO continues to develop FOTIVDA in immuno-oncology combinations in RCC and other indications, and has several other investigational programs in clinical development. AVEO is committed to creating an environment of diversity, equity and inclusion to diversify representation within the Company.
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.
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