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    Senior Manager, Pharmacovigilance

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    5+ years
    Not Disclosed
    Remote
    10 Oct. 7, 2024
    Job Description
    Job Type: 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 Manager, Pharmacovigilance

    Company Overview:

    ICON plc is a leading healthcare intelligence and clinical research organization dedicated to fostering an inclusive environment that drives innovation and excellence. Join us in our mission to shape the future of clinical development.

    At ICON, we support the entire clinical research process, providing outsourced services to pharmaceutical, biotechnology, medical device, and public health organizations. With patients at the heart of what we do, we accelerate the development of drugs and devices that save lives and enhance quality of life. Our people are our greatest asset, embodying our culture and driving our success. At ICON, our team is passionate about achieving excellence in everything we do.

    Position Summary:

    We are seeking a Senior Manager, Pharmacovigilance to oversee projects, ensuring profitability and alignment with company objectives. This role serves as a key contact for clients, managing the lifecycle of standalone projects and full-service initiatives.

    Key Responsibilities:

    • Monitor project performance to ensure profitability and meet project goals.
    • Act as the primary point of contact for clients throughout assigned projects and programs.
    • Develop and implement metrics and objectives for direct reports, monitoring their progress.
    • Identify and recommend process improvements based on project-specific plans.
    • Manage resource allocation and projections to align with client needs and contractual obligations.
    • Analyze project backlogs to ensure adequate resource availability for business objectives.
    • Oversee the creation of project plans, including Safety Management Plans (SMP) and SAE Reconciliation plans.
    • Deliver training on departmental and company processes to Pharmacovigilance staff.
    • Collaborate with functional managers to maintain consistency in pharmacovigilance practices.
    • Stay current with industry regulations and practices impacting services.
    • Review project tasks performed by Pharmacovigilance Associates and Specialists, providing leadership and guidance.
    • Support direct reports in identifying out-of-scope activities and efficiency needs.
    • Foster a culture of learning, self-improvement, and career development among staff.
    • Engage in recruitment processes for new team members.
    • Participate in business development initiatives, including presentations and proposal development.
    • Assist with audit preparations and respond to findings as needed.
    • Act as a Subject Matter Expert (SME) on various technologies or processes.
    • Develop and deliver training on pharmacovigilance topics for internal and external stakeholders.

    Requirements:

    • In-depth knowledge of local and global medical device regulations, ICH Guidelines, and pharmacovigilance practices.
    • Proven project management skills and ability to operate autonomously.
    • Strong planning, organization, and time management abilities.
    • Excellent communication skills, with a proven ability to build rapport with clients.
    • Highly motivated and proactive mindset.
    • Ability to effectively structure teams for scalable operations.

    What ICON Offers:

    At ICON, our success hinges on the capabilities and quality of our people. We are committed to a continuous learning culture that challenges you with engaging work and fosters professional development.

    We offer a comprehensive and competitive total rewards package, including:

    • Various annual leave entitlements
    • Comprehensive health insurance options
    • Competitive retirement planning offerings
    • Global Employee Assistance Programme, LifeWorks, for family well-being support
    • Life assurance and flexible, country-specific optional benefits, such as childcare vouchers, gym memberships, and health assessments.

    Equal Opportunity Statement:

    ICON, including its subsidiaries, is an equal opportunity and inclusive employer, committed to a discrimination-free workplace. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.

    If you require a reasonable accommodation during the application process or need assistance to perform the essential functions of a position due to a medical condition or disability, please let us know.

    Join Us:

    If you are interested in this role but feel you do not meet all the requirements, we encourage you to apply. You may be exactly what we’re looking for at ICON, whether for this position or others.

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