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Safety Writing Assistant Ii

0-2 years
Not Disclosed
10 Feb. 4, 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

Safety Writing Assistant II

Location: Mumbai
Category: Clinical
Job ID: 2443859

About Fortrea:

Fortrea is a leading global contract research organization (CRO) committed to scientific excellence and clinical development. With operations in approximately 100 countries, Fortrea offers innovative solutions across over 20 therapeutic areas, transforming drug and device development for patients and partners worldwide.

Role Overview:

As a Safety Writing Assistant II, you will be responsible for generating outputs and reports from safety databases and systems, supporting the medical writing team in preparing safety reports, and contributing to regulatory submissions. Your role will involve writing sections of various safety reports, including adverse drug experience and benefit-risk evaluation reports, as well as participating in signal detection activities.

Key Responsibilities:

  • Generate reports and outputs from safety systems, such as sales data calculations and regulatory website searches.
  • Author sections of safety reports for global regulatory submissions, including Annual Reports, Periodic Safety Update Reports, and Risk Management Plans.
  • Develop low to medium complexity report sections, annotate line listings, prepare case narratives, and present data according to the approved strategy.
  • Support signal detection activities by reviewing and annotating line listings, assisting in data cleaning, and preparing materials for signal review meetings.

Why Join Fortrea?

Fortrea is committed to solving complex challenges in clinical trials and revolutionizing drug and device development. Join our team for a dynamic and supportive work environment that fosters personal growth, and allows you to make a global impact.

For more information, visit www.fortrea.com.