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    Senior Pharmacovigilance Project Manager

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    2+ years
    Not Disclosed
    Remote, USA
    10 Nov. 4, 2024
    Job Description
    Job Type: Full Time Part Time Remote 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

    Senior Pharmacovigilance Project Manager - Remote
    Location: Blue Bell, PA

    Company Overview
    ICON plc is a leading healthcare intelligence and clinical research organization dedicated to shaping the future of clinical development. We pride ourselves on fostering an inclusive environment that drives innovation and excellence, and we invite you to join us on our mission to improve global health.

    Role Overview
    We are seeking a Senior Pharmacovigilance Project Manager to oversee a portfolio of pharmacovigilance projects, ranging from simple to complex, and spanning multiple business units and functional areas. In this role, you will provide valuable insights into how various areas impact one another while ensuring project success.

    Key Responsibilities

    Primary Customer Contact and Leadership

    • Serve as the primary project manager for a portfolio of pharmacovigilance projects, acting as the liaison between the client and project team on aspects such as time, scope, cost, quality, and resources.
    • Provide leadership and mentoring to project teams, ensuring timely delivery of all project deliverables.
    • Lead cross-functional teams, vendors, and third parties with minimal supervision.
    • Collaborate with functional leads to optimize performance and manage team feedback.
    • Monitor compliance with regulatory requirements, training, and budget constraints.
    • For complex projects, define success criteria, manage communication, and track deliverables to address issues and dependencies.

    Communication

    • Lead client and internal meetings, ensuring agendas and minutes are approved.
    • Present project status updates during internal reviews and financial meetings.
    • Act as a subject matter expert (SME) for pharmacovigilance proposals and lead bid defense processes.
    • Contribute to the development of practices and tools to enhance process improvements.
    • Stay informed about industry technologies, methods, and best practices.

    Delivery

    • Ensure project delivery aligns with contract requirements, achieving on-time and on-budget completion.
    • Develop and manage the Project Management Plan throughout the project lifecycle.
    • Oversee project plans, prioritize tasks, troubleshoot, and implement contingency plans for timely, high-quality delivery.
    • Prepare status reports for clients and leadership.

    Finance

    • Oversee project budgets, resource allocation, and invoice approvals.
    • Identify, negotiate, and execute contract modifications.
    • Conduct in-depth analysis of timelines and financials for senior management and clients.

    Qualifications

    • A minimum of 6 years of experience in pharmacovigilance as a project manager.
    • Experience working for a Contract Research Organization (CRO) or pharmaceutical company.
    • Bachelor’s degree.
    • Strong communication skills.

    Benefits of Working at ICON
    At ICON, we recognize that our success is driven by the quality and capabilities of our people. We are committed to fostering a continuous learning culture that challenges you with engaging work and contributes to your professional development.

    In addition to a competitive salary, ICON offers a comprehensive rewards package, including:

    • Various annual leave entitlements
    • Health insurance options tailored to you and your family’s needs
    • Competitive retirement planning offerings
    • Global Employee Assistance Program (LifeWorks) providing 24-hour access to support
    • Life assurance
    • Flexible benefits tailored to your location, including childcare vouchers, gym memberships, and more.

    To learn more about the benefits we offer, visit our careers site.

    Diversity and Inclusion
    At ICON, diversity, inclusion, and belonging are core to our culture and values. Our rich diversity drives innovation and helps us better serve our employees, patients, clients, and communities. We are dedicated to providing an inclusive and accessible environment for all candidates and committed to a workplace free from discrimination and harassment. All qualified applicants will receive equal consideration for employment regardless of race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.

    If you need a reasonable accommodation during the application process or to perform the essential functions of a position, please let us know through the appropriate request form.

    Application Encouragement
    If you’re interested in this role but unsure about meeting all requirements, we encourage you to apply anyway—you might be just what we’re looking for!

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