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    Pharmacovigilance Reporting Specialist

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    4-6 years
    Not Disclosed
    Bulgaria
    10 Nov. 23, 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

    Job Title: Pharmacovigilance Reporting Specialist

    Location: Sofia, Bulgaria
    Company: ICON plc

    About ICON plc

    ICON plc is a global leader in healthcare intelligence and clinical research. We work to accelerate drug and device development, improving patient outcomes and quality of life. Our inclusive culture fosters innovation and excellence, driven by our mission to shape the future of clinical development.

    Key Responsibilities

    • Safety Reporting:

      • Submit expedited Serious Adverse Event (SAE) reports, periodic reports, line listings, and other safety-related information to stakeholders (clients, Regulatory Authorities, Ethics Committees, investigators, etc.) within agreed timelines.
      • Release safety reporting intelligence in alignment with company procedures.

    • Expertise & Oversight:

      • Provide expertise in safety reporting processes and maintain deep knowledge of ICON’s safety reporting systems, SOPs, and guidance documents.
      • Lead and ensure accountability for safety reporting activities on assigned projects.
      • Oversee project compliance with ICON standards, regulatory requirements, and contractual obligations.

    • Collaboration & Communication:

      • Collaborate with project teams, client contacts, investigators, and third-party vendors.
      • Maintain and update project-related data across multiple databases.
      • Build strong relationships across functional units to ensure efficient workflows.

    • Quality Assurance:

      • Ensure all documents are filed and quality-checked for audits and inspections.
      • Support departmental SOP development and contribute to process improvements.

    • Additional Support:

      • Assist management with compliance metrics, finance tracking, resource allocation, training oversight, and corrective actions as needed.

    Requirements

    • Education: Bachelor’s degree in life sciences.
    • Experience: 4 to 6 years of relevant experience in pharmacovigilance.
    • Skills:
      • Fluency in English.
      • Proficient in working with databases and adhering to SOPs.
      • Strong organizational and communication skills.

    Why Join ICON?

    Career Development:
    ICON supports continuous learning and professional growth through engaging work and development programs.

    Comprehensive Benefits Package:

    • Competitive salary with variable pay programs.
    • Flexible health insurance options for you and your family.
    • Generous annual leave entitlements.
    • Retirement planning options to ensure a secure future.
    • Life assurance and optional benefits like discounted gym memberships, childcare vouchers, and more.
    • Access to the Global Employee Assistance Programme (LifeWorks) for you and your family’s well-being.

    Diversity & Inclusion:
    At ICON, diversity, inclusion, and belonging are central to our culture. We are dedicated to creating a workplace free of discrimination and harassment, providing equal opportunities to all qualified candidates.

    Reasonable Accommodations:
    If you require any accommodations due to a medical condition or disability, we are here to support you throughout the application process and your role.

    Interested?

    If this role aligns with your expertise, but you’re unsure about meeting all requirements, we still encourage you to apply. ICON values potential and looks for candidates who can bring diverse skills and perspectives to the table.

    Current ICON Employees: Click here to apply.

    Explore other opportunities and learn more about ICON at our Careers Site.

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