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    Pharmacovigilance Associate

    Iqvia
    0-1 years
    Not Disclosed
    Remote, USA
    10 July 30, 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, 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 Summary:

    The MI staff member will work in a Medical Call Center, responsible for all medical information duties to support clients in compliance with applicable regulations, company Standard Operating Procedures, and project-specific operational agreements. The role involves handling calls or making follow-up calls regarding various drug products, quality complaints, adverse events, and more.

    Job Responsibilities:

    • Medical Inquiries:

      • Respond to and process medical information inquiries from healthcare professionals, consumers, regulators, and internal colleagues.
      • Handle inquiries related to adverse events/reactions and product complaints for Clients’ products, following their agreement with ICON.
      • Triage information received based on regulatory requirements and applicable SOPs, ensuring proper handling of adverse events, product complaints, and medical information queries.

    • Case Management:

      • Conduct adverse event follow-up via phone or in writing, based on specific Client or case requirements.
      • Manage multiple projects within established time frames.
      • Oversee client projects, including managing client relationships and project budgets.

    • Communication and Data Management:

      • Monitor and manage project-specific email accounts, incoming faxes, and telephone calls.
      • Triaging incoming information to determine classification, priorities, and timelines for subsequent actions.
      • Enter information into medical information databases, tracking systems, and project-specific forms, ensuring accurate data entry.

    • Resource Management:

      • Maintain a library of responses to Frequently Asked Questions and Standard Response Letters.
      • Prepare Standard Response letters, including literature searches and article summaries.
      • Respond to medical information inquiries within set timelines, seeking assistance from clients and safety physicians as needed.

    • Compliance and Reporting:

      • Identify individual Case Safety Reports and technical product complaints, forwarding them to relevant stakeholders within predetermined timelines.
      • Assist with or perform reconciliation of safety databases, tracking systems, medical information databases, product complaint databases, and clinical databases.

    • Regulatory Expertise:

      • Monitor and interpret worldwide regulations related to medical information and pharmacovigilance, providing regulatory expertise to colleagues and clients.
      • Assist with regulatory agency inspections, client audits, and internal audits.

    • Team Collaboration:

      • Participate actively in multidisciplinary teams to achieve project and corporate goals.
      • Identify project issues and propose alternative strategies for discussion with superiors.
      • Perform other duties as assigned by the line manager that require similar skills.

    Requirements:

    • Strong written and oral communication skills in English.
    • Healthcare Professional (Doctor, Nurse, Pharmacist).
    • Additional language capabilities are an asset.

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