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    Director Of Pharmacovigilance Quality And Alliance Management

    Aveo Oncology
    10+ years
    Not Disclosed
    Remote, USA
    10 Nov. 5, 2024
    Job Description
    Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

    Job Title: Director of Pharmacovigilance Quality and Alliance Management
    Location: Boston or Remote
    Company: Aveo Oncology

    Job Summary

    The Director of Pharmacovigilance Quality and Alliance Management will be a critical member of the Pharmacovigilance (PV) team at Aveo Oncology. This role is responsible for ensuring the highest standards of drug safety and regulatory compliance within the organization. The Director will oversee the development and management of a Pharmacovigilance Quality Management System (PV QMS), ensure adherence to global regulatory standards (e.g., FDA, EMA, ICH), and manage strategic relationships with external partners and vendors. The Director will collaborate with cross-functional teams including clinical development, regulatory affairs, commercial, and external stakeholders to support the safe delivery of oncology therapies.

    Key Responsibilities

    Pharmacovigilance Quality Management:

    • Develop & Maintain PV QMS: Create, implement, and continuously improve a comprehensive Pharmacovigilance Quality Management System to ensure full compliance with global regulatory requirements.
    • Lead PV Audits: Conduct internal and external audits, including audits of CROs, vendors, and partners, to ensure adherence to SOPs, regulations, and industry best practices.
    • CAPA Management: Oversee the development and implementation of Corrective and Preventive Actions (CAPAs) following audits and inspections.
    • Process Improvement: Continuously monitor and analyze pharmacovigilance processes to identify areas for improvement and implement necessary changes.
    • Regulatory Inspections: Act as the primary point of contact for regulatory inspections related to pharmacovigilance, ensuring readiness for inspections at all times.

    Alliance Management:

    • Manage External Relationships: Build and manage strong relationships with external partners, including CROs, pharmaceutical partners, and other vendors involved in pharmacovigilance activities.
    • Contract Management: Negotiate, draft, and oversee pharmacovigilance agreements, ensuring clarity on roles and responsibilities regarding safety and quality.
    • Performance Monitoring: Monitor and assess the performance of external partners to ensure compliance with regulatory requirements and contractual obligations.
    • Facilitate Collaboration: Lead regular meetings with external partners to address performance, resolve issues, and identify opportunities for improvement.

    Strategic Leadership:

    • Leadership and Direction: Provide strategic direction and leadership to the Pharmacovigilance Quality and Alliance Management functions, ensuring alignment with the company’s business goals.
    • Industry Representation: Represent Aveo Oncology at industry forums, conferences, and regulatory discussions related to pharmacovigilance and quality management.

    Team Development & Management:

    • Lead & Mentor Teams: Lead a team of pharmacovigilance and quality management professionals, promoting a culture of continuous improvement.
    • Professional Development: Ensure the ongoing professional development of team members, offering training and growth opportunities.
    • Resource Management: Effectively allocate resources to meet the department’s objectives and overall company goals.

    Qualifications

    Education & Experience:

    • Advanced degree in a scientific discipline (preferred).
    • 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.
    • Strong background in alliance management, especially in the context of drug safety and pharmacovigilance.

    Skills & Competencies:

    • Strong leadership, communication, and negotiation skills.
    • Ability to thrive in a fast-paced, dynamic environment, collaborating with cross-functional teams.
    • Excellent analytical and problem-solving abilities.

    About Aveo Oncology

    Aveo Oncology is a commercial-stage, oncology-focused biopharmaceutical company dedicated to delivering innovative medicines that improve the lives of cancer patients. Aveo currently markets FOTIVDA® (tivozanib) in the U.S. for the treatment of adult patients with relapsed or refractory renal cell carcinoma (RCC). Aveo is also developing FOTIVDA in immuno-oncology combinations and other indications, with several additional investigational programs in clinical development. Aveo is committed to fostering an environment of diversity, equity, and inclusion.

    Equal Opportunity Employer

    Aveo Oncology is an Equal Opportunity Employer. We celebrate diversity and are committed to creating an inclusive environment for all employees. 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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