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    Senior Pharmacovigilance Project Manager (Post Marketing)

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    5+ years
    Not Disclosed
    Remote, USA
    10 Nov. 5, 2024
    Job Description
    Job Type: Full 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

    Job Title: Senior Pharmacovigilance Project Manager (Post-Marketing)
    Location: Remote (Blue Bell, PA)
    Company: ICON plc

    About ICON plc

    ICON plc is a global leader in healthcare intelligence and clinical research. We partner with life sciences companies to improve patients' lives by advancing clinical development. ICON is proud to foster a culture of innovation, excellence, and inclusion, where diverse teams collaborate to drive meaningful outcomes in the healthcare sector.

    Our "Own It" culture is rooted in four core values: Accountability & Delivery, Collaboration, Partnership, and Integrity. At ICON, we aim to be the partner of choice in drug development, delivering excellence for both our clients and patients.

    We invite you to join us in shaping the future of clinical research and making an impact on the healthcare industry.

    Role Overview

    We are seeking a Senior Pharmacovigilance Project Manager to lead and manage Post-Marketing Pharmacovigilance (PV) projects at ICON. This role involves overseeing the delivery of PV services across multiple functional areas, ensuring quality, compliance, and timelines are met. The Senior PV Project Manager will serve as the primary point of contact for clients, manage cross-functional teams, and be responsible for ensuring the successful execution of post-marketing pharmacovigilance projects.

    Key Responsibilities

    Project Leadership & Client Liaison:

    • Lead and manage a portfolio of post-marketing pharmacovigilance projects, ensuring customer expectations are met.
    • Act as the primary point of contact between the client and ICON’s internal teams, ensuring the delivery of high-quality results within agreed timelines and budget.
    • Provide leadership, guidance, and mentorship to project teams, ensuring deliverables are met with quality and efficiency.
    • Collaborate with functional leads to manage operational aspects such as safety reporting, case processing, and surveillance.

    Communication & Stakeholder Engagement:

    • Lead client and internal meetings, ensuring clear communication of project status, risks, and mitigation strategies.
    • Serve as a subject matter expert (SME) during proposal development and bid defense processes.
    • Contribute to the creation and refinement of internal practices and processes to improve project delivery and operational efficiency.

    Project Delivery & Management:

    • Manage the complete lifecycle of PV projects, ensuring the on-time and on-budget completion of deliverables.
    • Oversee the development and execution of project plans, including troubleshooting and contingency planning.
    • Regularly monitor and update project timelines, budget, and resource allocation to ensure smooth project delivery.
    • Prepare and present project status reports to clients and senior leadership.

    Financial Management & Contract Oversight:

    • Oversee project budgets, resource allocation, and approval of invoices.
    • Negotiate and execute contract modifications when necessary, ensuring financial and contractual compliance.
    • Analyze timelines and financials to provide senior management and clients with in-depth project insights.

    Qualifications

    • Experience: A minimum of 6 years in pharmacovigilance project management, with expertise in post-marketing clinical trials.
    • Knowledge: Strong understanding of pharmacovigilance operations and related regulatory requirements.
    • Background: Experience working with a Contract Research Organization (CRO) or pharmaceutical company is preferred.
    • Education: Bachelor’s degree in life sciences or a related field.
    • Communication: Excellent verbal and written communication skills with the ability to present complex information clearly to various stakeholders.

    Why Work at ICON?

    ICON is committed to building a diverse and inclusive workforce that drives high performance and fosters innovation. As a part of our team, you'll enjoy:

    • Competitive Salaries & Bonuses: Attractive salary packages and performance-based bonuses.
    • Comprehensive Benefits: Including health insurance, retirement plans, life assurance, and more.
    • Work-Life Balance: Flexible work options and generous annual leave.
    • Professional Development: Access to ongoing learning and career growth opportunities.
    • Global Support: Benefit from a wide range of resources, including a Global Employee Assistance Program offering 24/7 access to expert advice and counseling.

    Diversity & Inclusion at ICON

    ICON is an equal opportunity employer committed to building a diverse and inclusive workforce. We provide equal consideration for employment without regard to race, color, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.

    We also offer reasonable accommodations for candidates with disabilities during the application process or in performing job functions. If you need assistance, please submit a request here.

    Interested in the role? Apply today to join a leading company at the forefront of clinical research and healthcare innovation.

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