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    Senior Manager, Pharmacovigilance

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    5+ years
    Not Disclosed
    Remote
    10 Nov. 4, 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

    Senior Manager, Pharmacovigilance
    Location: Remote

    Company Overview
    ICON plc is a leading healthcare intelligence and clinical research organization dedicated to advancing clinical research from molecule to medicine. We are proud to foster an inclusive environment that drives innovation and excellence. Join us in our mission to shape the future of clinical development and improve quality of life for patients worldwide.

    Role Overview
    As a Senior Manager in Pharmacovigilance, you will be responsible for monitoring projects to ensure company profitability and that project goals and objectives are met. You will serve as the main point of contact for clients throughout the lifecycle of assigned projects and programs, ensuring effective communication and resource management.

    Key Responsibilities

    • Monitor projects to assure profitability and achieve project objectives.
    • Act as the primary point of contact for customers on standalone projects and as the main pharmacovigilance contact for full-service projects.
    • Develop and implement profitability metrics and objectives for direct reports.
    • Identify and recommend process improvements within your service area based on project-specific plans.
    • Manage resources to align with client needs, expectations, and contractual obligations.
    • Analyze project backlog to ensure adequate resources are available to meet business objectives.
    • Provide technical oversight for the generation of project plans, including Safety Management Plans (SMP) and SAE Reconciliation plans.
    • Deliver training on department-related topics to pharmacovigilance staff.
    • Collaborate with other functional managers to ensure consistency in pharmacovigilance approaches.
    • Review project tasks of Pharmacovigilance Associates and Specialists, providing leadership in service delivery.
    • Support direct reports in identifying out-of-scope activities and efficiency improvement needs.
    • Ensure compliance with company and client Quality Management Systems (QMS), policies, and procedures.
    • Foster a culture of learning, self-improvement, and career development for staff.
    • Participate in recruitment for new employees in the assigned service area.
    • Assist in business development initiatives and maintain relationships with existing clients.
    • Ensure timely and accurate proposal submissions for new business opportunities.
    • Support audit preparation and respond to findings as necessary.
    • Act as a Subject Matter Expert (SME) for various technologies and processes.
    • Develop and deliver training courses on pharmacovigilance topics to both internal and external audiences.
    • Represent the pharmacovigilance service area in global initiatives and make autonomous decisions with minimal supervision.

    Requirements

    • Thorough working knowledge of local and global medical device Health Authority regulations, guidelines, and ICH Guidelines.
    • Effective project management skills and the ability to make decisions independently.
    • Strong planning, organizational, and change management skills.
    • Ability to build and maintain rapport with clients; experience in client interactions is advantageous.
    • Highly motivated and proactive with the ability to scale team structures effectively.

    Benefits of Working at ICON
    At ICON, we believe our success depends on the knowledge and quality of our people. We are committed to a culture of continuous learning and development. Our comprehensive total rewards package includes:

    • Competitive salary and variable pay programs.
    • Extensive health insurance offerings.
    • Retirement planning options.
    • Global Employee Assistance Program (LifeWorks) with 24/7 access to support.
    • Life assurance and flexible country-specific benefits tailored to your needs.

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

    Diversity and Inclusion
    At ICON, diversity, inclusion, and belonging are fundamental to our culture and values. We are dedicated to providing an inclusive and accessible environment for all candidates and are 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, 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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