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    Pharmacovigilance Reporting Specialist

    Icon
    2+ years
    Not Disclosed
    Remote, USA
    10 Nov. 18, 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

    Pharmacovigilance Reporting Specialist - Sofia, Bulgaria

    ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development.

    At ICON, our people are our greatest strength. We provide outsourced services to pharmaceutical, biotechnology, medical device, and government and public health organizations, advancing clinical research from molecule to medicine. Our work accelerates the development of drugs and devices that save lives and improve quality of life.

    Key Responsibilities:

    • Submission of expedited Serious Adverse Event (SAE) reports, periodic reports, line listings, and safety information to clients, Regulatory Authorities, Ethics Committees, investigators, third-party vendors, Partners, and ICON personnel within project timelines.
    • Release safety reporting intelligence for expedited and periodic reports to Regulatory Authorities, Ethics Committees, and investigators.
    • Provide in-depth expertise regarding safety reporting processes and maintain understanding of ICON's safety reporting systems and conventions.
    • Perform technical and process oversight of safety reporting services on assigned projects.
    • Ensure compliance with ICON, Sponsor, and regulatory timeframes for safety information reporting.
    • Serve as support for Safety Reporting Group management in all aspects of departmental activities, including quality review, finance tracking, client engagement, and CAPA oversight.
    • Collaborate with project team members, clients, investigators, and vendors to maintain relationships across functional units.
    • Work with multiple databases to update project or safety reporting intelligence information.
    • Assist in the development of Standard Operating Procedures (SOPs) and Work Procedures.

    Requirements:

    • Bachelor's degree in life sciences.
    • 4 to 6 years of experience in pharmacovigilance.
    • Fluency in English.

    Benefits:

    ICON offers a comprehensive and competitive total reward package, including:

    • Annual leave entitlements.
    • Health insurance offerings to suit you and your family’s needs.
    • Retirement planning options.
    • Global Employee Assistance Programme (LifeWorks).
    • Life assurance and additional optional benefits, including childcare vouchers, discounted gym memberships, and health assessments.

    Why Join ICON?

    At ICON, we value diversity, inclusion, and belonging, and our commitment to these principles fuels our innovation and helps us better serve our people, patients, customers, and communities. We believe in developing our employees through continuous learning and offering a variety of benefits tailored to support you and your family at all stages of your career.

    ICON is an equal opportunity employer and committed to providing a workplace free of discrimination and harassment.

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