Apply for Sr Safety Writer at Fortrea 2026. Check eligibility, salary, pharmacovigilance experience, responsibilities, and application process details online now today.
Introduction
With the growing importance of drug safety and pharmacovigilance, skilled medical writers are in high demand across global CROs. The Sr. Safety Writer at Fortrea is an excellent opportunity for professionals with experience in safety writing and regulatory documentation. This role allows you to work on global submissions, signal detection, and benefit-risk analysis while mentoring junior team members.
Job Overview
| Details | Information |
|---|---|
| Job Title | Sr. Safety Writer |
| Company Name | Fortrea |
| Location | Mumbai, India |
| Employment Type | Full-Time |
| Department | Pharmacovigilance / Medical Writing |
| Experience Required | 4+ Years |
| Education | Life Sciences Degree (Advanced Degree Preferred) |
| Salary | As per company norms |
Company Overview
Fortrea is a globally recognized contract research organization specializing in clinical development, pharmacovigilance, and regulatory services. The company partners with pharmaceutical and biotech firms to ensure safe and efficient drug development, offering employees exposure to global projects and cutting-edge clinical research practices.
Job Location & Employment Type
The role is based in Mumbai, India, and is a full-time position. Some travel (around 10%) may be required depending on project needs.
Open Positions / Department Details
This position is part of the Safety Writing and Pharmacovigilance team, where the selected candidate will handle safety report writing, signal detection activities, and regulatory documentation.
Key Roles & Responsibilities
- Write and review safety reports such as PSUR, PADER, DSUR, and benefit-risk reports
- Prepare regulatory documents including Clinical Overviews and CTD summaries
- Author Risk Management Plans (RMPs) and signal evaluation reports
- Manage end-to-end report lifecycle including planning, review, and submission
- Participate in signal detection and safety analysis processes
- Draft responses to health authority queries
- Develop manuscripts, abstracts, and conference materials
- Conduct literature reviews and safety data analysis
- Update product labels such as CDS, USPI, and SPC
- Train and mentor junior medical writers
- Support project management activities and track deliverables
- Ensure compliance with ICH-GCP and pharmacovigilance guidelines
- Collaborate with cross-functional teams and clients
Eligibility Criteria
Education
- Bachelor’s degree in Life Sciences (mandatory)
- Master’s degree or PhD preferred
Experience
- Minimum 4 years of pharmaceutical industry experience
- At least 3 years of experience in medical writing
- Experience in pharmacovigilance and safety writing preferred
Skills Required
- Strong knowledge of safety writing and regulatory documentation
- Understanding of pharmacovigilance processes and signal detection
- Familiarity with ICH-GCP and global regulatory guidelines
- Excellent English writing and communication skills
- Strong analytical and problem-solving abilities
- Ability to manage multiple projects and deadlines
- Leadership and mentoring skills
Salary & Benefits
- Salary: As per company norms
- Opportunity to work on global safety and regulatory projects
- Exposure to international clients and regulatory authorities
- Career growth in pharmacovigilance and medical writing
- Learning and development programs
- Professional and collaborative work environment
Selection Process
The hiring process generally includes:
- Resume screening
- HR interview
- Technical/functional interview
- Final managerial round
How to Apply
Interested candidates can apply through the official Fortrea careers portal. Make sure your resume highlights your experience in safety writing, regulatory submissions, and pharmacovigilance.
Important Dates
- Last Date to Apply: Not specified (Apply early)
Why Apply for This Job?
The Sr. Safety Writer at Fortrea offers a strong platform for professionals aiming to advance in pharmacovigilance and medical writing. With responsibilities spanning safety reporting, signal detection, and mentoring, this role helps build leadership skills while working on global regulatory submissions. It is an ideal step toward senior roles in drug safety and regulatory affairs.
FAQs
1. What experience is required for this role?
Candidates need at least 4 years of pharma experience with 3 years in medical writing.
2. What type of documents will I work on?
You will work on PSUR, DSUR, RMPs, CTD summaries, and safety reports.
3. Is pharmacovigilance knowledge required?
Yes, knowledge of safety writing and pharmacovigilance is important.
4. Is a master’s degree mandatory?
No, but it is preferred.
5. Is travel required for this role?
Yes, approximately 10% travel may be required.
Conclusion
The Sr. Safety Writer role at Fortrea is a valuable opportunity for experienced medical writers looking to grow in pharmacovigilance and regulatory writing. With global exposure, leadership responsibilities, and career advancement potential, this role is ideal for building a strong future in the pharmaceutical industry. Apply early to secure your chance.
Disclaimer
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