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    Manager, Pharmacovigilance

    Icon
    3+ years
    Not Disclosed
    Bulgaria
    12 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

    Job Description: Pharmacovigilance Manager

    Location: Office-based, Bulgaria
    Company: ICON plc

    Overview:

    ICON plc is a global leader in healthcare intelligence and clinical research, committed to innovation and excellence. We are seeking a Pharmacovigilance Manager to join our team in Bulgaria. In this role, you will manage personnel within the Pharmacovigilance department, focusing on overseeing the team’s activities, ensuring regulatory compliance, and driving process improvements.

    Responsibilities:

    • Team Management & Leadership:

      • Oversee daily operations of the Pharmacovigilance team, ensuring that project goals and company profitability are met.
      • Develop and monitor team objectives, metrics, and performance, providing guidance and leadership to your team members.
      • Lead, mentor, and coach staff, supporting their professional development and creating an environment conducive to learning and growth.
      • Participate in recruitment processes, ensuring that new employees are properly onboarded and trained.

    • Process Improvement & Project Oversight:

      • Identify and implement process improvements through the review of project-specific plans, SOPs, and business processes.
      • Monitor and allocate resources effectively to meet client needs and contractual obligations.
      • Ensure timely and accurate generation of safety management plans, SAE reconciliation plans, and other related documents.
      • Participate in business development, including proposal development and client meetings, to maintain and grow client relationships.

    • Regulatory Compliance & Documentation:

      • Ensure compliance with regulatory requirements related to pharmacovigilance, safety reporting, and adverse event management.
      • Oversee the preparation and submission of Standard Response letters, literature searches, and other relevant documents.
      • Support audit preparation and follow-up, ensuring that audit findings are addressed in a timely manner.
      • Ensure that all activities comply with company policies, procedures, and regulatory standards.

    • Client Interaction & Business Development:

      • Engage with clients to support new business opportunities and maintain strong relationships with existing clients.
      • Assist in preparing for audits, responding to audit findings as necessary.

    Qualifications:

    • Education:

      • Bachelor’s degree (or higher) in a healthcare-related or life sciences field.

    • Experience:

      • Minimum of 3 years of experience as a Pharmacovigilance Manager within a CRO or BPO environment.
      • Broad knowledge of clinical development and safety requirements, from pre-clinical to post-marketing.

    • Skills:

      • Strong leadership skills with proven experience in managing diverse, globally distributed teams.
      • Excellent project management skills with the ability to manage multiple priorities.
      • Analytical mindset with a focus on data-driven decision-making.
      • Excellent command of the English language (written and spoken).

    What ICON Offers You:

    ICON provides a range of competitive benefits designed to support your well-being and career development. Benefits include:

    • Various annual leave entitlements
    • A range of health insurance options
    • Competitive retirement planning offerings
    • Global Employee Assistance Programme (LifeWorks)
    • Life assurance
    • Flexible country-specific optional benefits (childcare vouchers, gym memberships, travel passes, health assessments, etc.)

    At ICON, diversity, inclusion, and belonging are central to our culture, and we are committed to providing an inclusive environment for all candidates.

    Interested?
    If you're passionate about pharmacovigilance and clinical research and meet the qualifications outlined, we encourage you to apply

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