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    Executive Director, Pharmacovigilance, Safety Technical Operations

    Thermo Fisher Scientific
    7+ years
    Not Disclosed
    Remote
    10 Dec. 11, 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 Operations
    Location: Not Specified
    Work Schedule: Standard (Mon-Fri)
    Environmental Conditions: Office

    Job Description:

    The Director of Pharmacovigilance Operations is responsible for overseeing the operational excellence of the department, providing strategic leadership, guidance, and technical expertise to direct reports in one or more specialty areas. This role ensures the operational success of the department by driving key goals and initiatives, partnering with Senior Leadership to achieve operational and financial success. The Director will identify and develop business opportunities, collaborate with stakeholders on enterprise-wide initiatives, and promote a culture of accountability and continuous improvement.

    Key Responsibilities:

    Operational Leadership:

    • Manage department staff, including recruitment, training, professional development, and performance management.
    • Oversee staffing decisions, salary administration, corrective actions, and terminations.
    • Ensure adherence to Equal Employment Opportunity policies and Affirmative Action plans while maintaining high ethical and regulatory standards.
    • Provide leadership and technical expertise to support business-critical functions.
    • Ensure infrastructure, systems, processes, and policies are developed and executed to support pharmacovigilance (PV) operations effectively.

    Strategic Planning & Business Development:

    • Drive PV technology strategy to support client needs and future business goals.
    • Lead business development initiatives, including writing and reviewing proposals, presenting capabilities to potential clients, and managing client relationships.
    • Actively engage in external governance meetings and client strategic initiatives.
    • Oversee budget management, including annual and long-term forecasting, training, and process improvement activities.

    Cross-functional Collaboration:

    • Work with senior leadership to develop corporate policies, business plans, and strategies to improve operational performance.
    • Liaise with cross-functional teams and clients to ensure smooth execution of PV operations and meet strategic business objectives.

    Risk & Compliance Management:

    • Oversee the management and maintenance of PV systems to ensure compliance with regulatory requirements.
    • Lead efforts in adopting new technologies and solutions to enhance PV processes.
    • Assess and manage risks related to PV integration, including during mergers and acquisitions.

    Education & Experience:

    • 15+ years of relevant experience in pharmacovigilance operations.
    • At least 8 years of management experience, including overseeing Argus support and vendor management.
    • Proven success in leading and mentoring experienced PV technical teams, fostering a culture of continuous improvement.
    • Experience developing and executing strategic plans to drive PV business growth.
    • Strong background in regulatory compliance, including GCPs, FDA/ICH guidelines, and international regulatory authorities.
    • Expertise in the drug development lifecycle, from clinical trials to post-market authorization.

    Knowledge, Skills, and Abilities:

    • Ability to influence in matrix environments, both within and outside of the department.
    • Extensive knowledge of PV systems and regulatory requirements.
    • Expert skills in strategic planning, budgeting, forecasting, and fiscal management.
    • Ability to lead cross-functional teams, resolve complex issues, and mitigate risks.
    • Strong communication and negotiation skills, with experience presenting services to sponsors and preparing proposals for PV and regulatory affairs activities.
    • Change management experience, building motivated, integrated teams that deliver high-quality work on time and within budget.

    Management Role:

    This is a senior managerial role, overseeing global or regional operations, or managing multiple departments. In some cases, the role may focus on a functional area with no direct reports, depending on executive management decisions.

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