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    Senior Manager, Pharmacovigilance

    Icon
    2+ years
    Not Disclosed
    Bulgaria
    10 Nov. 26, 2024
    Job Description
    Job Type: Remote Education: B.Sc./M.Sc./B.Pharm/M.Pharm/Life science 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

    Position: Senior Manager, Pharmacovigilance
    Location: Flexible Global Locations

    ICON plc, a leading healthcare intelligence and clinical research organization, is seeking a Senior Manager, Pharmacovigilance to provide leadership and expertise in pharmacovigilance processes, ensuring the safety and efficacy of medical products while contributing to innovation and compliance in clinical research.

    Key Responsibilities

    • Project Oversight:

      • Monitor pharmacovigilance projects to meet profitability, quality, and timeline objectives.
      • Act as the primary pharmacovigilance contact for standalone and full-service projects.

    • Operational Leadership:

      • Develop and implement resource plans to align with project goals.
      • Lead the creation and quality oversight of Safety Management Plans (SMPs) and SAE Reconciliation Plans.
      • Manage and optimize workflows for improved efficiency.

    • Team Development:

      • Provide mentorship, performance feedback, and career development support to team members.
      • Deliver training on pharmacovigilance processes and ICON systems to internal teams and external stakeholders.

    • Client Interaction:

      • Maintain strong client relationships, participating in client meetings and business development initiatives.
      • Represent ICON in industry settings, contributing to thought leadership via publications and presentations.

    • Regulatory and Quality Compliance:

      • Stay abreast of local and global health authority regulations and ICH guidelines.
      • Ensure team adherence to quality management systems (QMS), SOPs, and regulatory standards.
      • Support audits, resolve findings, and ensure readiness for inspections.

    • Strategic Contribution:

      • Participate in global initiatives impacting pharmacovigilance.
      • Act autonomously as a Subject Matter Expert (SME) for technologies and processes.
      • Identify and drive process improvements and innovation within the pharmacovigilance function.

    Required Skills and Qualifications

    • Education and Experience:

      • Bachelor’s degree in a relevant field (Life Sciences preferred). Advanced degree advantageous.
      • Extensive experience in pharmacovigilance, clinical research, or related domains.
      • Proven ability to lead teams in a global, matrixed environment.

    • Technical Skills:

      • In-depth knowledge of global pharmacovigilance regulations and ICH guidelines.
      • Strong project management and organizational skills.
      • Proficiency with pharmacovigilance and safety reporting systems.

    • Interpersonal Skills:

      • Strong leadership, decision-making, and change management abilities.
      • Excellent client-facing skills with a proven track record of fostering client relationships.
      • Effective communication and presentation skills for diverse audiences.

    • Additional Skills:

      • Experience with resource planning and financial forecasting.
      • A proactive approach to process improvements and operational efficiency.

    Why Join ICON?

    At ICON, we prioritize the well-being and growth of our people. Our comprehensive rewards package includes:

    • Competitive Compensation: Attractive base salary with performance-based incentives.
    • Health & Well-being Benefits: Customized health insurance plans, global Employee Assistance Program, and more.
    • Work-Life Balance: Flexible working arrangements and annual leave entitlements.
    • Professional Growth: Opportunities for continuous learning, training, and certifications.
    • Inclusive Environment: A diverse workplace where innovation and collaboration thrive.

    If you’re passionate about advancing clinical research and shaping the future of pharmacovigilance, we encourage you to apply.

    Visit ICON Careers to learn more about this role and the opportunities at ICON.

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