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    Drug Safety Specialist

    Barrington James
    3-5 years
    Not Disclosed
    Remote
    10 Jan. 15, 2025
    Job Description
    Job Type: Full Time 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

    Interim Drug Safety Specialist (6-Month Contract)

    Location: Remote/Flexible (EU based ONLY)
    Contract Type: 6-Month Contract (20 Hours/Week)
    Start Date: 28/01/2025

    Job Description:
    We are seeking an Interim Drug Safety Specialist to support pharmacovigilance activities on a 6-month contract. The role involves ensuring regulatory compliance for Individual Case Safety Reports (ICSRs), preparing safety reports, contributing to Risk Management Plans (RMPs), and liaising with regulatory authorities. You will be responsible for managing safety data, identifying potential safety signals, and supporting clinical trials and post-marketing drug safety phases.

    Key Responsibilities:

    • Collect, review, and process Individual Case Safety Reports (ICSRs) in compliance with regulatory timelines and internal SOPs.
    • Ensure accurate data entry into safety databases and maintain meticulous records.
    • Assist in identifying and analyzing potential safety signals.
    • Support the preparation of safety reports, including PSURs and DSURs.
    • Liaise with regulatory authorities to resolve drug safety queries.
    • Contribute to the development and review of Risk Management Plans (RMPs).
    • Provide input on safety aspects during clinical trials and post-marketing phases.
    • Ensure adherence to Good Pharmacovigilance Practices (GVP).

    Qualifications & Skills:

    • Bachelor’s degree in pharmacy, life sciences, or related field (advanced degree preferred).
    • 3-5 years of experience in pharmacovigilance/drug safety, including case processing and regulatory submissions.
    • Proficiency in pharmacovigilance databases and tools.
    • Familiarity with global regulatory guidelines (e.g., EMA, FDA, ICH).
    • Strong analytical skills with attention to detail.
    • Excellent written and verbal communication skills.
    • Ability to work independently and manage time effectively in a remote environment.

     

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