Apply for Principal Safety Writer at Fortrea 2026. Check eligibility, salary, experience, pharmacovigilance role details, and application process online now today.
Introduction
Pharmacovigilance and safety writing are among the most critical functions in the pharmaceutical industry today. The Principal Safety Writer at Fortrea role is a senior-level opportunity for experienced medical writers who want to lead global safety reporting projects and work on high-impact regulatory submissions. This position is ideal for professionals with strong expertise in drug safety, risk evaluation, and scientific writing.
Job Overview
| Details | Information |
|---|---|
| Job Title | Principal Safety Writer |
| Company Name | Fortrea |
| Location | Mumbai, India |
| Employment Type | Full-Time |
| Department | Pharmacovigilance / Medical Writing |
| Experience Required | 5–7 Years |
| Education | Life Sciences Degree (Advanced Degree Preferred) |
| Salary | As per company norms |
Company Overview
Fortrea is a leading global CRO offering clinical development and regulatory services to pharmaceutical and biotechnology companies. The organization specializes in clinical trials, pharmacovigilance, and safety reporting, helping bring innovative therapies to market while ensuring patient safety and compliance with international regulations.
Job Location & Employment Type
This role is based in Mumbai, India, with flexibility for office-based or remote work depending on project requirements. It is a full-time position with opportunities for global exposure.
Open Positions / Department Details
The position is part of the Pharmacovigilance and Safety Writing team, where the candidate will lead safety document preparation, signal detection activities, and benefit-risk evaluations for global regulatory submissions.
Key Roles & Responsibilities
- Lead preparation and review of safety and pharmacovigilance documents
- Author reports such as PSUR, DSUR, PADER, Clinical Overviews, and RMPs
- Manage end-to-end delivery of safety writing projects
- Act as the primary client contact for safety reporting activities
- Provide guidance and mentorship to medical writing teams
- Participate in signal detection and safety evaluation processes
- Support benefit-risk analysis and regulatory decision-making
- Draft responses to health authority queries
- Contribute to scientific publications, abstracts, and conference materials
- Conduct literature reviews and develop research strategies
- Support label updates such as CDS, USPI, and SPC
- Collaborate with cross-functional teams for project execution
- Maintain compliance with global regulatory guidelines (ICH, GCP, PV practices)
- Drive process improvements and quality enhancement initiatives
Eligibility Criteria
Education
- Bachelor’s degree in Life Sciences (mandatory)
- Master’s degree or PhD preferred
Experience
- 5 to 7 years of pharmaceutical industry experience
- Minimum 4 years of experience in medical writing
- Experience in pharmacovigilance and safety writing required
- Exposure to global regulatory submissions (US, EU, etc.) preferred
Skills Required
- Strong expertise in safety and regulatory writing
- Knowledge of pharmacovigilance practices and signal management
- Understanding of ICH-GCP guidelines and regulatory frameworks
- Excellent written and verbal communication skills
- Leadership and mentoring capabilities
- Strong analytical and problem-solving skills
- Ability to manage multiple projects and deadlines
- Proficiency in MS Office tools
Salary & Benefits
- Salary: As per company norms
- Leadership role in pharmacovigilance and medical writing
- Opportunity to work on global regulatory submissions
- Exposure to international clients and safety projects
- Career growth in drug safety and regulatory affairs
- Learning and development programs
Selection Process
The hiring process typically includes:
- Resume shortlisting
- HR interview
- Technical/functional interview
- Final managerial round
How to Apply
Interested candidates can apply through the official Fortrea careers portal. Ensure your resume highlights your experience in safety writing, pharmacovigilance, and regulatory submissions.
Important Dates
- Last Date to Apply: April 14, 2026
Why Apply for This Job?
The Principal Safety Writer at Fortrea is a high-impact role offering leadership responsibilities in pharmacovigilance and medical writing. Candidates will work on complex safety data, interact with global clients, and contribute to regulatory decision-making. This role provides excellent career progression into senior leadership positions in drug safety and regulatory affairs.
FAQs
1. What experience is required for this role?
Candidates need 5–7 years of pharmaceutical experience with at least 4 years in medical writing.
2. Is pharmacovigilance experience mandatory?
Yes, experience in safety writing and pharmacovigilance is essential.
3. What documents will I work on?
You will work on PSUR, DSUR, RMPs, clinical overviews, and other safety reports.
4. Is this a remote job?
It can be office-based or remote depending on project requirements.
5. What is the last date to apply?
The last date to apply is April 14, 2026.
Conclusion
The Principal Safety Writer role at Fortrea is an excellent opportunity for experienced professionals aiming to lead in pharmacovigilance and regulatory writing. With global exposure, leadership responsibilities, and career advancement opportunities, this role is ideal for those looking to grow in the clinical research and pharmaceutical industry. Apply soon to secure your chance.
Disclaimer
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