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Safety Writing Assistant Ii

0-2 years
Not Disclosed
10 Jan. 18, 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

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


Job Overview

Fortrea is looking for a motivated and detail-oriented Safety Writing Assistant II to support activities such as generating reports from safety systems, preparing regulatory documents, and assisting in signal detection activities. The ideal candidate will author sections of safety reports and collaborate with medical writers on data review and case narrative preparation.

Key Responsibilities

  • Report Generation:
    • Generate outputs and reports from safety databases or safety systems.
    • Distribute data requests, perform sales data calculations, and conduct regulatory website searches.
    • Collate materials for report planning.
  • Report Writing:
    • Author parts of various safety reports for global regulatory submissions, such as Annual Reports (IND and other), Periodic Safety Update Reports, and Risk Management Plans.
    • Develop sections with pre-populated templates or reuse content from other documents, focusing on low to medium complexity safety analyses.
    • Review and annotate line listings and prepare case narratives or data summaries.
    • Participate in comment resolution for assigned sections.
  • Signal Detection Support:
    • Assist medical writers in signal detection activities, including data cleaning, review, and annotation of line listings.
    • Create supporting material for signal review meetings and prepare parts of signal reports.

Company Overview

Fortrea is a global contract research organization (CRO) specializing in clinical development and technology solutions across more than 20 therapeutic areas. With operations in over 90 countries, Fortrea is committed to transforming the drug and device development process to deliver life-changing therapies to patients.

Equal Opportunity Employer Statement

Fortrea is an Equal Opportunity Employer and is committed to fostering diversity and inclusion. We do not tolerate harassment or discrimination and make employment decisions based on the qualifications of the individual and the needs of the business.

Accommodation

Fortrea provides reasonable accommodations for individuals who require assistance during the hiring process. Please contact taaccommodationsrequest@fortrea.com for accommodation requests.