Life Sciences Jobs at Fortrea | Candidates Apply Now
Are you looking for Life Sciences Jobs in medical writing with a leading global clinical research organisation? Fortrea Careers is hiring Safety Writers for its Mumbai and Pune locations. This is an excellent opportunity for candidates with experience in Medical Writing Jobs, pharmacovigilance, and regulatory documentation to work on global safety reports, risk management documents, and clinical writing projects. If you have a background in life sciences and are looking to grow your career, explore this exciting opportunity today.
About Fortrea
Fortrea is a leading global contract research organisation (CRO) providing clinical development, patient access, and technology solutions to pharmaceutical, biotechnology, and medical device companies. The company supports clinical research across multiple therapeutic areas with expertise in regulatory, pharmacovigilance, and medical writing services. Fortrea Careers offers professionals the opportunity to work on global healthcare projects while contributing to the development of innovative medicines and improving patient outcomes.
Job Overview
Fortrea Careers is inviting applications for the position of Safety Writer. This full-time hybrid opportunity is based in Mumbai and Pune. The role involves preparing and reviewing aggregate safety reports, risk management documents, signal detection reports, and regulatory submissions while ensuring compliance with global pharmacovigilance guidelines. This is an excellent opportunity for professionals seeking Life Sciences Jobs and Medical Writing Jobs in a globally recognised organisation.
Key Responsibilities
- Prepare and review aggregate safety, risk management, and signal detection documents.
- Perform report management activities and lead client communication for assigned reports.
- Assist medical writers in safety deliverables and act as a co-author for complex reports.
- Perform quality review of reports prepared by junior and associate medical writers.
- Conduct scientific literature searches and review literature for safety reports and surveillance activities.
- Collect data for report planning, develop strategies, and lead kick-off meetings.
- Write global regulatory safety reports, including:
- Annual Reports (IND and others)
- Periodic Safety Update Reports (PSUR)
- Periodic Adverse Drug Experience Reports (PADER)
- Development Safety Update Reports (DSUR)
- Risk Management Plans (RMP)
- Other regulatory safety documents
- Prepare benefit-risk evaluation reports and supporting documents for label updates.
- Write Common Technical Document (CTD) summaries, Clinical Overviews, Clinical Summaries, and Non-Clinical Overviews.
- Prepare medical information responses for healthcare professionals (HCPs).
- Author signal reports, safety issue analysis reports, and adverse event narratives.
- Coordinate with internal teams and clients for project inputs.
- Participate in creating and updating Core Data Sheets, USPIs, SPCs, and Medication Guides.
- Review literature search strategies and prepare literature summaries.
- Promote quality processes and ensure the timely delivery of documents.
- Ensure compliance with regulatory requirements and SOPs.
- Maintain excellent customer service standards.
- Perform additional project-related activities as assigned.
Qualifications
- Minimum first degree in Life Sciences or equivalent.
- Relevant equivalent experience may be considered in place of educational qualifications.
- An advanced degree, such as a Master’s or PhD, is preferred.
Experience
- Minimum 3 years of experience in the pharmaceutical industry.
- Or at least 2 years of experience in Medical Writing Jobs.
- Scientific or clinical research experience is desirable.
Skills Needed
- Excellent written and spoken English.
- Strong written and verbal communication skills.
- Knowledge of Microsoft Office.
- Good organisational and time management skills.
- Excellent interpersonal skills.
- Understanding of regulatory requirements.
- Knowledge of Pharmacovigilance practices.
- Understanding of ICH-GCP guidelines.
- Ability to manage multiple projects and timelines.
- Willingness to travel up to 5% as required.
If you are searching for Life Sciences Jobs, Fortrea Careers offers an excellent opportunity to build your future in Medical Writing Jobs. Apply for the Safety Writer position today and take the next step toward a rewarding career in pharmacovigilance, regulatory writing, and global clinical research.
