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Fortrea
Fortrea Hiring Safety Writer in Mumbai
Fortrea is hiring a Safety Writer for its Mumbai location. This is a full-time opportunity for professionals with experience in pharmacovigilance and medical writing to work on global safety reports and regulatory documents.
Job Details
- Company: Fortrea
- Role: Safety Writer
- Location: Mumbai
- Job Type: Full-Time
- Job ID: 261164
Key Responsibilities
- Prepare and review aggregate safety reports and risk management documents
- Write regulatory documents like:
- PSUR, DSUR, PADER, IND Annual Reports
- Conduct signal detection and safety analysis
- Perform quality review of reports from junior writers
- Author:
- Benefit-risk reports
- Clinical & non-clinical summaries (CTD documents)
- Draft adverse event narratives and safety issue reports
- Support labeling updates (Core Data Sheets, USPI, SPCs)
- Conduct scientific literature searches & reviews
- Collaborate with internal teams and clients
- Ensure compliance with regulatory guidelines and SOPs
Qualifications
- Bachelor’s degree in Life Sciences (or equivalent)
- Advanced degree (MSc/PhD) – Preferred
Experience Required
- Minimum 3 years in pharma industry
- OR
- Minimum 2 years in medical writing
Skills Required
- Strong English writing & communication skills
- Knowledge of MS Office tools
- Understanding of:
- Pharmacovigilance practices
- ICH-GCP guidelines
- Good time management & organizational skills
- Scientific/clinical research knowledge (preferred)
Work Environment
- May require ~5% travel, including overnight stays
Why Join Fortrea?
- Work on global regulatory safety documents
- Exposure to international clients
- Opportunity to grow in drug safety & medical writing
- Collaborative and professional work environment
📌 How to Apply
Interested candidates can apply directly through the official Fortrea careers portal using Job ID 261164.
To apply for this job please visit fortrea.wd1.myworkdayjobs.com.
