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Sr. Safety Writer

Fortrea
Fortrea
3-4 years
Not Disclosed
Mumbai, India
10 April 22, 2026
Job Description
Job Type: Full Time Education: Advanced degree (e.g., PhD or Masters) preferred. 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

Job Title:

Senior Medical Writer (Safety & Pharmacovigilance)


Job Overview:

The Senior Medical Writer is responsible for leading the preparation and review of aggregate safety reports, risk management documents, signal detection outputs, and benefit-risk evaluations. This role involves end-to-end report management, ensuring high-quality deliverables within timelines, while also mentoring junior team members and supporting project management activities.


Key Responsibilities:

Medical Writing & Regulatory Documentation:

  • Author and review global safety and regulatory reports, including:
    • Annual Reports (IND and others)
    • Periodic Safety Update Reports (PSUR)
    • Periodic Adverse Drug Experience Reports (PADER)
    • Periodic Benefit-Risk Evaluation Reports (PBRER)
    • Development Safety Update Reports (DSUR)
    • Addendum and ad hoc reports
  • Prepare Risk Management Plans (RMPs) and medical device reports
  • Write Common Technical Document (CTD) summaries:
    • Clinical Overviews & Summaries
    • Non-Clinical Overviews

Signal Detection & Safety Analysis:

  • Perform and review signal detection activities
  • Support signal strategy and safety review meetings
  • Conduct literature and database searches for safety evaluation
  • Author:
    • Signal reports (periodic and ad hoc)
    • Safety issue analysis reports

Labeling & Benefit-Risk Evaluation:

  • Create and update product labeling documents:
    • Core Data Sheets (CDS)
    • USPI, SPCs, Medication Guides
  • Recommend and justify label changes
  • Prepare supporting documentation for regulatory submissions

Publications & Scientific Communication:

  • Author/review:
    • Manuscripts
    • Abstracts
    • Posters for conferences
  • Prepare medical information responses for healthcare professionals (HCPs)

Training & Mentorship:

  • Coach and mentor junior medical writers
  • Conduct training sessions and provide hands-on learning opportunities
  • Act as a writing coach and develop training programs

Project Management & Coordination:

  • Manage end-to-end report lifecycle: planning, authoring, review, approval, submission
  • Coordinate with internal teams and external clients
  • Track deliverables, timelines, and quality metrics
  • Assist in resource estimation and RFP responses

Quality, Compliance & Process Improvement:

  • Ensure compliance with:
    • Regulatory requirements
    • Pharmacovigilance practices
    • ICH-GCP guidelines
  • Perform quality checks and maintain documentation
  • Author/review SOPs, WIs, and process documents
  • Promote efficient, standardized processes

Additional Responsibilities:

  • Draft responses to health authority queries
  • Resolve project-related issues
  • Conduct literature reviews for surveillance and reporting
  • Contribute to continuous improvement and client satisfaction

Qualifications (Minimum Required):

  • Bachelor’s degree in Life Sciences or equivalent
  • Equivalent experience may be considered

Experience Required:

  • Minimum 4 years in the pharmaceutical industry
    • Including at least 3 years in medical writing

Skills & Competencies:

  • Excellent written and spoken English proficiency
  • Strong scientific writing and communication skills
  • Knowledge of MS Office tools
  • Good organizational and time management skills
  • Strong interpersonal and teamwork abilities
  • Understanding of:
    • Regulatory requirements
    • Pharmacovigilance practices
    • ICH-GCP guidelines

Preferred Qualifications:

  • Advanced degree (Master’s or PhD) in a relevant field
  • Experience in scientific or clinical research

Work Environment:

  • Office or remote work setup
  • Willingness to travel (~10%), including overnight stays if required