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    Senior Manager, Pharmacovigilance

    Icon Plc
    3-5 years
    Not Disclosed
    Bulgaria
    10 Nov. 23, 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

    Company Overview:

    ICON plc is a world-leading healthcare intelligence and clinical research organization committed to shaping the future of clinical development. ICON supports pharmaceutical, biotechnology, medical device, and public health organizations, accelerating the development of life-saving drugs and devices. With a culture that values innovation and excellence, ICON fosters an inclusive environment where our people drive success and progress.

    Role Overview:

    ICON is seeking a Senior Manager, Pharmacovigilance to oversee a diverse range of projects and lead a talented team within the pharmacovigilance service area. You will be responsible for ensuring the profitability, efficiency, and regulatory compliance of pharmacovigilance services, while driving process improvements and fostering client relationships. This role will involve strategic oversight, client interactions, staff development, and acting as a subject matter expert (SME) in the field.

    Key Responsibilities:

    • Project Management & Leadership:

      • Monitor project performance to ensure profitability and alignment with project goals.
      • Serve as the primary contact for clients on assigned projects, ensuring successful execution and meeting client expectations.
      • Manage resources and set objectives for the team, ensuring adherence to client needs and contractual obligations.
      • Drive continuous improvement in processes and service delivery through the review of project plans and SOPs.

    • Staff Development & Training:

      • Provide leadership, mentorship, and career development opportunities for pharmacovigilance staff.
      • Organize training sessions for internal staff and external parties on pharmacovigilance topics, maintaining a focus on industry best practices.
      • Support recruiting efforts for new employees and ensure efficient team scaling.

    • Regulatory Compliance & Process Oversight:

      • Ensure the compliance of pharmacovigilance operations with local and global regulatory requirements and ICH guidelines.
      • Oversee the development of safety management plans (SMPs), SAE reconciliation plans, and other project documentation.
      • Collaborate with cross-functional teams to ensure consistent pharmacovigilance practices across the company.

    • Client & Business Development:

      • Maintain strong relationships with clients, identifying new business opportunities and ensuring ongoing satisfaction.
      • Lead business development initiatives, including proposal preparation and client meetings.
      • Participate in industry events, presenting ICON’s capabilities and writing articles for industry publications.

    • Audit & Quality Assurance:

      • Support the audit process, ensuring all necessary documentation is provided, and respond to audit findings as needed.
      • Oversee the coordination of interdepartmental activities to ensure quality control and compliance.

    • Subject Matter Expertise (SME):

      • Act as an SME for pharmacovigilance technologies and processes, providing expert guidance and decision-making.
      • Represent ICON in global pharmacovigilance initiatives, making decisions with minimal supervision.

    Requirements:

    • Education:

      • Thorough working knowledge of global medical device regulations, ICH guidelines, and pharmacovigilance best practices.
      • Bachelor’s degree in a healthcare-related or life sciences field (advanced degree preferred).

    • Experience:

      • Extensive experience in pharmacovigilance management, including project management and client interactions.
      • Strong background in regulatory affairs and the ability to make independent decisions with minimal supervision.
      • Proven leadership skills with the ability to manage and develop a high-performing team.

    • Skills:

      • Excellent planning, organizational, and time management skills.
      • Ability to drive process improvements and identify efficiencies within the team.
      • Strong interpersonal skills for building relationships with clients and internal teams.
      • Proactive, highly motivated, and capable of managing multiple priorities.

    Benefits of Working at ICON:

    ICON offers a competitive and comprehensive benefits package designed to support both your professional and personal well-being, including:

    • Health insurance options for you and your family
    • Competitive retirement planning options
    • Global Employee Assistance Programme (LifeWorks)
    • Life assurance
    • Various flexible, country-specific benefits, including childcare vouchers, gym memberships, and more

    ICON is committed to building a diverse, inclusive workplace where all employees can thrive, and we welcome applicants from all backgrounds.

    Interested?
    We encourage you to apply for the Senior Manager, Pharmacovigilance role, even if you are unsure about meeting every requirement. ICON values talent, passion, and commitment, and there’s every chance you’re exactly what we’re looking for.

     

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