Fortrea Lifescience jobs as a Senior Safety Writer – PhD/M.Sc Lifescience candidates
About Fortrea:
Fortrea is a pioneering pharmaceutical company that specializes in safety writing and regulatory compliance. We are committed to delivering high-quality services to our clients while fostering a culture of innovation and excellence.
Job Title: Senior Safety Writer
Job Location: Remote: Hybrid locations in Mumbai
Job Type: Full-Time
Posted On: Posted Today
End Date to Apply: April 24, 2025
Job Requisition ID: 251685
Job Overview:
Lead the preparation and review of aggregate safety, risk management, signal detection, and benefit-risk evaluation reports. Be responsible for end-to-end report management, including planning, authoring, and managing review, approval, and submission steps, per project scope and requirements. Apply safety domain knowledge and process expertise to manage deliverables of medium to high complexity. Ensure timely delivery of high-quality documents to internal customers and sponsors/clients. Coach, mentor, and provide shadowing opportunities and hands-on experience for the training and development of medical writers and junior associates. Support project management activities. Foster excellent working relationships with all clients, both internal and external, with the highest quality of service in a cost-effective manner on time, every time.
Summary of Responsibilities:
- Write and review global safety reports (e.g., IND Annual Reports, PSURs, PADERs, DSURs, RMPs, ad-hoc reports).
- Author CTD summaries, clinical and non-clinical overviews, and regulatory documents.
- Draft responses to health authority queries and coordinate cross-functional feedback.
- Conduct training, mentor junior writers, and develop training programs.
- Prepare medical information responses and review signal detection activities.
- Author safety signal reports, safety issue analyses, and manuscripts for conferences.
- Develop and review SOPs, process documents, and labeling materials (e.g., Core Data Sheets, USPI, SPCs).
- Perform literature searches, review safety data, and support signaling strategy meetings.
- Manage project coordination, resource estimation, client communications, and issue resolution.
- Ensure compliance with regulatory requirements and maintain high-quality deliverables.
Qualifications (Minimum Required):
- Minimum of first degree in life sciences (or equivalent).
- Fortrea may consider relevant and equivalent experience in lieu of educational requirements.
- At least 4 years’ experience in the pharmaceutical industry, or at least 3 years of it in medical writing.
Experience (Minimum Required):
- Excellent command of written and spoken English.
- Good written and verbal communication skills.
- Knowledge of MS Office.
- Good organizational and time management ability.
- Excellent interpersonal skills.
- Scientific or Clinical research experience desirable.
- Good understanding of regulatory requirements, good Pharmacovigilance practices and ICH GCP guidelines.
Preferred Qualifications Include:
- Advanced degree (e.g., PhD or Masters) preferred.
Physical Demands/Work Environment:
- Available for travel 10% of the time including overnight stays as necessary consistent with project needs and office location.
Keywords: Senior Safety Writer, Fortrea, Mumbai, Full-Time, Remote, Hybrid, Pharmaceutical Industry, Regulatory Compliance, Fortrea Lifescience jobs
