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Fortrea, a global leader in clinical development and pharmacovigilance services, is hiring an experienced Safety Analysis Scientist for its Mumbai location. This is a senior-level pharmacovigilance medical writing role involving aggregate safety reporting, signal detection, benefit–risk evaluation, and regulatory submissions for global clients.
This opportunity is ideal for professionals with strong experience in pharmacovigilance medical writing, ICH guidelines, and global regulatory safety reports who are ready to take on technical leadership responsibilities.
📍 Location: Mumbai (Also open for Manila)
🕒 Job Type: Full Time
📅 Last Date to Apply: 02 January 2026
🆔 Job Requisition ID: 255966
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🔍 Key Responsibilities – Safety Analysis Scientist
As a Safety Analysis Scientist at Fortrea, you will:
- Lead and review aggregate safety reports including:
- PSUR / PBRER
- DSUR
- PADER
- IND Annual Reports
- Clinical Overviews & Medical Device Safety Reports
- Independently manage end-to-end safety report production, ensuring quality and regulatory compliance.
- Act as technical lead for medical writing teams across multiple safety projects.
- Serve as primary client contact for safety deliverables and stakeholder communication.
- Author and review Risk Management Plans (RMPs), benefit–risk evaluations, and ad hoc safety reports.
- Participate in signal detection and signal management, including safety issue analysis.
- Support labeling activities (USPI, Core Data Sheets, SmPC, Medication Guides).
- Draft health authority responses and collaborate with cross-functional stakeholders.
- Contribute to scientific publications, abstracts, posters, and conference presentations.
- Coach and mentor junior writers; promote best practices and style guide adherence.
- Support project management, audits, metrics tracking, and process improvement initiatives.
- Contribute to business development activities, including RFP responses and effort estimation.
🎓 Qualifications & Experience Required
Minimum Qualifications
- Bachelor’s degree in Life Sciences (Master’s or PhD preferred)
- Fortrea may consider equivalent relevant experience
Experience
- 5–7 years in the pharmaceutical industry
- Minimum 4 years in medical writing / safety writing
- Strong knowledge of:
- Pharmacovigilance regulations
- ICH GCP, ICH E2 guidelines
- US FDA, EMA, and global regulatory submissions
- Excellent written and spoken English
- Proven leadership, mentoring, and stakeholder management skills
- Strong understanding of the drug development lifecycle
💼 Benefits of Working at Fortrea
- Work on global pharmacovigilance projects
- High-impact role with scientific leadership exposure
- Opportunity to publish and represent Fortrea at conferences
- Hybrid/remote flexibility (project dependent)
- Career growth in a globally recognized CRO
- Collaborative, quality-driven work culture
📝 How to Apply
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