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Fortrea
Safety Writer Vacancy for Life Science Graduates | Fortrea Mumbai
Apply for Fortrea Safety Writer vacancies in Mumbai. Open for life science graduates with 3+ years of pharma/medical writing experience.
Fortrea, a trusted global leader in clinical development and pharmaceutical services, is currently hiring for the role of Safety Writer at its Mumbai location. This position is ideal for life science professionals with strong expertise in pharmacovigilance, medical writing, and safety documentation. If you are passionate about regulatory writing and safety compliance, this opportunity allows you to contribute directly to global healthcare and regulatory submissions.
Company Overview
Fortrea is a global contract research organization (CRO) providing comprehensive drug development and safety services to pharmaceutical, biotechnology, and healthcare companies worldwide. With a strong focus on regulatory compliance, pharmacovigilance, and clinical development, Fortrea supports clients in bringing safer, effective medicines to patients faster. The company’s collaborative environment empowers employees to excel in complex healthcare projects while maintaining high ethical and regulatory standards.
Job Role & Responsibilities
As a Safety Writer at Fortrea, you will be responsible for preparing and reviewing safety reports, risk management documentation, and regulatory submissions. Your responsibilities will include:
- Writing safety reports for global regulatory submissions including Annual Reports (IND), PSURs, PADERs, DSURs, Risk Management Plans, and related documents.
- Leading report management activities, client communications, and project strategy discussions.
- Reviewing and ensuring the quality of safety reports authored by peers or junior writers.
- Authoring signal reports, safety issue analyses, adverse event narratives, and benefit-risk evaluation reports.
- Writing CTD Summaries (non-clinical, clinical, and overviews) for regulatory submissions.
- Conducting scientific literature searches for safety reports and routine surveillance.
- Preparing medical information responses for healthcare professionals.
- Contributing to labeling documents such as Core Data Sheets, USPIs, SPCs, and Med Guides.
- Ensuring regulatory compliance with ICH-GCP, pharmacovigilance guidelines, and safety requirements.
- Collaborating with cross-functional teams and clients to ensure timely, high-quality deliverables.
Eligibility / Qualifications
- Education: Minimum of a bachelor’s degree in Life Sciences, Pharmacy, Biotechnology, Microbiology, or related fields. Advanced degrees (M.Sc, M.Pharm, PhD) preferred.
- Experience: At least 3 years in the pharmaceutical industry, with a minimum of 2 years in medical writing/safety writing.
- Technical Skills:
- Excellent command of written and spoken English.
- Strong understanding of pharmacovigilance, regulatory guidelines, and ICH-GCP.
- Proficiency in MS Office Suite and document management tools.
- Strong organizational and time management skills.
- Desirable: Clinical research exposure and prior experience in safety surveillance.
Relevant courses include: B.Pharm, M.Pharm, M.Sc Life Sciences, M.Sc Clinical Research, M.Sc Biotechnology, PhD (Pharmacology, Toxicology, or related fields).
Location & Salary
- Location: Mumbai, India.
- Work Type: Full-time, on-site.
- Salary: Competitive salary aligned with pharmaceutical industry standards, plus benefits, performance incentives, and growth opportunities.
Application Process
Fortrea is committed to building a diverse, inclusive workforce where all employees are respected and empowered. Interested candidates are encouraged to apply before the application deadline.
FAQs
1. Who can apply for the Safety Writer role?
Candidates with a bachelor’s or higher degree in life sciences, pharmacy, or related fields and relevant industry experience in medical writing or pharmacovigilance.
2. What experience is required?
At least 3 years in the pharma industry, including 2 years in safety or medical writing.
3. What are the key responsibilities of this role?
Authoring and reviewing global safety reports, regulatory documents, risk management plans, and safety narratives.
4. Where is the job located?
The role is based in Mumbai, India.
5. Is travel required?
Yes, up to 5% travel may be required depending on project needs.
Job Summary Table
| Category | Details |
|---|---|
| Company | Fortrea |
| Vacancies | Safety Writer |
| Required Education | B.Pharm, M.Pharm, M.Sc Life Sciences, Biotechnology, Clinical Research, PhD |
| Experience | Minimum 3 years (with 2 years in medical writing/safety writing) |
| Location | Mumbai, India |
To apply for this job please visit fortrea.wd1.myworkdayjobs.com.