Jobs in Life Sciences | Fortrea Hiring Safety Writer | Apply Now
Are you looking to build a strong career in scientific writing, drug safety, and regulatory documentation? This Safety Writer position at Fortrea offers an excellent opportunity for professionals searching for jobs in life science, passionate about clinical safety, and eager to grow in writer jobs within a global CRO environment. Fortrea is known for providing exceptional exposure to pharmacovigilance, aggregate reporting, signal detection, and medical communication, making it an ideal workplace for individuals who want to advance their Fortrea Career and contribute to improving patient safety worldwide.
- Job Title: Safety Writer
- Locations: Mumbai
- Time Type: Full time
- Job Requisition ID: 254757
About the Company
Fortrea is a world-leading Contract Research Organization (CRO) offering comprehensive clinical research, regulatory, pharmacovigilance, and medical writing services for global pharmaceutical and biotech clients. With a mission to accelerate drug development and enhance patient outcomes, Fortrea provides end-to-end scientific support across clinical phases and post-marketing safety. A Fortrea career means joining a diverse, collaborative, and innovation-driven environment. The company empowers professionals through continuous learning, global project exposure, and opportunities to work on critical drug safety and regulatory documentation. Whether you’re exploring jobs in life science or aiming for long-term growth in writer jobs, Fortrea is a trusted platform for career excellence.
Key Responsibilities
- Prepare and review aggregate safety reports including PSURs, DSURs, PADERs, Annual Reports, RMPs, and related documents.
- Contribute to benefit-risk assessments, label justification reports, and regulatory summaries.
- Write clinical and non-clinical CTD summaries as assigned.
- Conduct scientific literature searches for safety surveillance.
- Review abstracts and propose company comments for inclusion.
- Lead kick-off meetings, discussions, and stakeholder communication.
- Coordinate with internal and external teams for high-quality submissions.
- Perform quality checks of reports authored by junior writers.
- Ensure compliance with GVP, ICH-GCP, SOPs, and regulatory standards.
- Maintain timelines and documentation accuracy.
- Prepare medical information responses for HCPs.
- Support creation and updating of product labels (CDS, USPI, SmPC).
- Perform other project-related tasks as assigned.
Educational Qualifications
- Bachelor’s degree in Life Sciences or equivalent.
- Advanced degree (MSc/PhD) preferred.
Experience Requirements
- Minimum 3 years of pharmaceutical industry experience.
- Minimum 2 years in medical writing (safety/regulatory preferred).
- Strong understanding of pharmacovigilance, regulatory guidelines, and safety reporting.
- Excellent command over written and spoken English.
Skills Required
- Strong scientific writing skills.
- Understanding of regulatory and safety guidelines (ICH, GVP, GCP).
- Knowledge of MS Office and literature databases.
- Ability to manage timelines and multitask.
- Strong interpersonal and communication skills.
The Safety Writer role at Fortrea is a remarkable opportunity for professionals looking to strengthen their scientific writing expertise and build a long-term career in drug safety and regulatory documentation. If you are exploring jobs in life science, want to establish yourself in writer jobs, and aspire to grow in a reputable global CRO, then this Fortrea Career opportunity is the perfect fit.
