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    Senior Manager, Pharmacovigilance

    Icon
    3-5 years
    Not Disclosed
    Bulgaria Remote
    12 Nov. 26, 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 Manager, Pharmacovigilance
    Location: Flexible (Global)
    Job Type: Full-Time

    Company Overview:
    ICON plc is a world-leading healthcare intelligence and clinical research organization, advancing clinical research to accelerate the development of drugs and devices that save lives and improve quality of life. The company fosters an inclusive environment and offers a diverse culture focused on innovation and excellence.

    Key Responsibilities:

    • Project Management:

      • Monitor and ensure project profitability, objectives, and goals are met.
      • Serve as the main point of contact for clients on assigned standalone and full-service pharmacovigilance projects.

    • Process Improvement:

      • Analyze and recommend improvements to project plans and processes to enhance efficiency.
      • Ensure resources are aligned with project needs and timelines.

    • Team Leadership & Development:

      • Oversee direct reports, provide leadership, training, mentorship, and career development opportunities.
      • Ensure staff adherence to company policies, SOPs, and quality standards.

    • Client Relations & Business Development:

      • Maintain strong client relationships and support business development efforts.
      • Participate in proposal development and client presentations.

    • Regulatory Oversight & Compliance:

      • Ensure projects are compliant with local/global medical device regulations, policies, and ICH guidelines.
      • Prepare and review Safety Management Plans and SAE reconciliation plans.

    • Training & Thought Leadership:

      • Lead training initiatives on pharmacovigilance topics for internal teams and clients.
      • Participate in industry conferences, publish articles, and maintain industry certifications.

    Requirements:

    • Experience:

      • Extensive experience in pharmacovigilance with strong leadership skills.
      • In-depth understanding of local and global medical device regulations, ICH guidelines, and project management.

    • Skills:

      • Excellent planning, organizational, people, time, and change management skills.
      • Proactive and highly motivated with the ability to work autonomously.
      • Strong interpersonal and client management abilities.

    • Education:

      • Relevant degree or experience in pharmacovigilance or related fields.

    Benefits of Working at ICON:

    • Competitive salary with additional variable pay and recognition programs.
    • Comprehensive health insurance and retirement planning options.
    • Work-life balance with flexible benefits and well-being initiatives.
    • Career development and learning opportunities in a diverse and inclusive environment.

    About ICON’s Culture:
    ICON fosters a diverse, inclusive culture and offers equal opportunities for all candidates. The company is committed to creating an accessible and supportive work environment, and encourages applications from all qualified individuals.

    This is an exciting opportunity to join a global leader in clinical development, with a focus on pharmacovigilance and project management.

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