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Senior Drug Safety Associate

2-4 years
Not Disclosed
10 Feb. 10, 2025
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

Department: Pharmacovigilance

Qualification:

  • Graduate/Post Graduate/Doctorate degree in Life Sciences, Pharmacy, Medical Sciences, or an equivalent field.
  • Fluency in English.

Mode of Work:

  • On-premise

Job Description:

  1. Case Processing & Data Entry:

    • Enter individual case safety reports (ICSRs) into the safety database.
    • Review and evaluate adverse event (AE) case information to determine necessary actions in accordance with internal policies and procedures.
    • Ensure timely processing of all incoming cases to meet regulatory and internal timelines.
    • Conduct full data entry, including medical coding and safety narrative documentation.
  2. Medical Coding & Narrative Writing:

    • Code medical history, adverse events, drugs, procedures, indications, and laboratory tests using appropriate dictionaries (e.g., MedDRA, Company Product Dictionary, WHO-DD).
    • Write medically relevant safety narratives for cases, ensuring completeness and accuracy of entered data.
  3. Literature Search & Follow-Ups:

    • Conduct literature searches for relevant safety information.
    • Follow up with sites regarding outstanding queries and case-related discrepancies.
    • Reconcile discrepancies and ensure accurate documentation.
  4. Workflow & Compliance:

    • Follow departmental AE workflow procedures to maintain consistency and regulatory compliance.
    • Perform case closure and deletion tasks as required.
    • Conduct submission activities when trained and assigned.
    • Adhere to good documentation practices for audit and inspection readiness.
  5. Additional Responsibilities:

    • Support other drug safety-related activities as assigned.
    • Ensure compliance with global pharmacovigilance regulations and internal standards.

This role requires strong attention to detail, regulatory knowledge, and the ability to ensure accurate and timely case processing for effective pharmacovigilance operations.