Fortrea is a leading global contract research organization (CRO) that partners with biopharmaceutical and medical device companies to deliver innovative solutions in clinical development and commercialization. With a strong focus on pharmacovigilance, regulatory compliance, and patient safety, Fortrea provides end-to-end support to ensure the highest standards in drug safety and efficacy.
1. Safety Writer – Mumbai (Hybrid)
Job ID: 251686
Application Deadline: April 17, 2025 (13 days left)
Job Description
The Safety Writer will be responsible for preparing and reviewing aggregate safety reports, risk management documents, and signal detection analyses. This role involves collaborating with internal and external stakeholders to ensure timely and high-quality regulatory submissions.
Key Responsibilities:
✔ Prepare Periodic Safety Update Reports (PSURs), Development Safety Update Reports (DSURs), Risk Management Plans (RMPs)
✔ Conduct scientific literature searches for safety surveillance
✔ Review and ensure compliance with ICH-GCP, FDA, EMA guidelines
✔ Assist junior writers in complex report preparations
✔ Coordinate with clients for necessary inputs and approvals
Qualifications & Experience:
- Bachelor’s/Master’s in Life Sciences, Pharmacy, or related field
- 3+ years in pharmacovigilance/medical writing (pharma/CRO preferred)
- Strong regulatory knowledge in drug safety
- Proficiency in MS Office, literature databases
📌 Preferred: Advanced degree (PhD/MSc)
2. Senior Safety Writer – Mumbai (Hybrid)
Job ID: 251685
Application Deadline: April 24, 2025 (20 days left)
Job Description
The Senior Safety Writer will lead the preparation of aggregate safety reports, benefit-risk evaluations, and regulatory submissions, while mentoring junior writers.
Key Responsibilities:
✔ Author DSURs, PSURs, RMPs, CTD summaries
✔ Lead signal detection and benefit-risk assessments
✔ Train & mentor junior medical writers
✔ Draft responses to health authority queries
✔ Support label updates (USPI, Core Data Sheets)
Qualifications & Experience:
- Bachelor’s/Master’s in Life Sciences/Pharmacy
- 4+ years in pharma industry (3+ in medical writing)
- Expertise in regulatory guidelines (GVP, ICH-GCP)
- Strong scientific writing & leadership skills
📌 Preferred: PhD or advanced degree
3. Medical Contact Center Assistant – Pune (On-site)
Job ID: 25290
Application Deadline: April 4, 2025 (Last Day!)
Job Description
This role involves handling medical inquiries, adverse event (AE) reporting, and product quality complaints via calls, emails, and faxes.
Key Responsibilities:
✔ Record & report Adverse Drug Reactions (ADRs) per regulatory timelines
✔ Respond to medical information queries
✔ Maintain safety database entries
✔ Support QC, data reconciliation, and compliance checks
Qualifications & Experience:
- Bachelor’s in Pharmacy/Life Sciences/Nursing
- 1+ years in pharmacovigilance/drug safety (or 3-4 years in pharma)
- Basic knowledge of GVP, ICH-GCP
- Strong communication & detail orientation
📌 Preferred: Experience in AE case processing
How to Apply?
Application Link For Safety Writer
Application Link For Senior Safety Writer
Application Link For Medical Contact Center Assistant
