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Principal Safety Writer

5-7 years
Not Disclosed
10 Jan. 18, 2025
Job Description
Job Type: Full Time Education: PhD/M.Sc/B.Sc 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: Principal Safety Writer
Location: Mumbai
Category: Clinical
Job ID: 2447515


Job Overview

Fortrea is seeking a highly experienced Principal Safety Writer to lead the preparation and review of safety reports, including complex data analyses and safety issues. The role involves acting as a technical lead for medical writing teams, ensuring high-quality safety deliverables, and maintaining strong client communication. The Principal Safety Writer will play a key role in signal detection, risk management, and benefit-risk evaluation reports, while also contributing to scientific publications and business development.

Key Responsibilities

  • Report Writing & Review:
    • Lead the writing and review of safety reports, including Annual Reports (IND and others), Periodic Safety Update Reports, and Risk Management Plans (RMPs).
    • Manage end-to-end report production and ensure quality standards and timelines are met.
    • Act as the primary point of contact for clients and stakeholders, ensuring the quality and timely delivery of reports.
  • Signal Management:
    • Lead/participate in the signal management process and author/review signal evaluation and management reports.
    • Provide inputs for developing signal strategies and data retrieval from safety databases.
  • Scientific Publication & Presentations:
    • Contribute to abstracts, posters, manuscripts, and other materials for scientific conferences and publications.
    • Represent the company at scientific meetings and forums.
  • Training & Mentoring:
    • Act as a writing coach, providing feedback, training, and best practices to associates.
    • Support project management activities, including maintaining project schedules and tracking metrics.
  • Client Communication:
    • Maintain good client communication to manage stakeholder expectations and resolve project/report issues.
    • Assist with business development activities, including RFP responses and resource estimation.
  • Compliance & Process Improvement:
    • Ensure compliance with regulatory requirements and participate in quality and process improvement initiatives.

Qualifications

  • Minimum Requirements:
    • First degree in life sciences (or equivalent).
    • At least 5-7 years of experience in the pharmaceutical industry, with at least 4 years in medical writing.
    • Strong command of written and spoken English.
    • Experience with regulatory requirements, pharmacovigilance practices, and ICH GCP guidelines.
    • Strong organizational, time management, and leadership skills.
  • Preferred Qualifications:
    • Advanced degree (e.g., PhD or Masters).
    • Experience in drug discovery and pharmacovigilance.
    • Ability to work independently and mentor team members.

Physical Demands/Work Environment

  • Office or remote environment.
  • Available for travel (15% of the time) including overnight stays as necessary.

Company Overview

Fortrea is a global CRO specializing in clinical development, patient access, and technology solutions across over 20 therapeutic areas. Fortrea is dedicated 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 qualifications and business needs.

Accommodation

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