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Safety Writing Assistant Ii

0-2 years
Not Disclosed
10 April 10, 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

Job Title: Safety Writing Assistant II
Location: Mumbai
Category: Clinical
Job ID: 2443859


Company Overview:

Fortrea is a global contract research organization (CRO) operating in ~100 countries, providing a range of clinical development, patient access, and technology solutions across 20+ therapeutic areas. They aim to transform the development of drugs and devices for better patient outcomes.


Summary of Responsibilities:

  • Perform allied safety writing activities including:

    • Generation of outputs/reports from safety systems or databases.

    • Distribution of data requests.

    • Sales data calculations.

    • Regulatory website searches.

    • Collation of report planning materials.

  • Author parts of safety reports for global regulatory submissions:

    • Annual Reports (IND and other), PSURs, PADERs, PBRERs, DSURs, RMPs.

  • Contribute to report development using:

    • Template text, re-used content, or sections involving low to medium complexity data analysis.

  • Review and annotate line listings, prepare case narratives and data summaries.

  • Participate in comment resolution discussions for assigned sections.

  • Support medical writers in signal detection tasks, including:

    • Data cleaning, line listing reviews, preparation of signal review materials, and drafting parts of signal reports.