Safety Writer fresher vacancies available at Fortrea
- Fortrea Hiring Safety Writer in Mumbai | 2–3 Years Medical Writing & Pharmacovigilance Role
- Company Overview
- Job Role & Responsibilities
- Key Responsibilities:
- Eligibility / Qualifications
- Educational Background:
- Experience Required:
- Skills Required:
- Location & Salary
- Application Process
- Why This Role Matters in Healthcare
- Frequently Asked Questions (FAQs)
- 1. Is this role suitable for freshers?
- 2. What reports will I work on?
- 3. Is pharmacovigilance knowledge required?
- 4. What career growth can I expect?
- Summary
Fortrea Hiring Safety Writer in Mumbai | 2–3 Years Medical Writing & Pharmacovigilance Role
Looking to advance your career in medical writing and pharmacovigilance? Fortrea is hiring Safety Writers in Mumbai for professionals with 2–3 years of experience in medical writing, safety reporting, and regulatory documentation. This is a full-time opportunity to work on global safety reports, risk management plans, and regulatory submissions.
This role offers strong exposure to aggregate safety reporting, signal detection, and benefit-risk evaluation, making it a high-value career move in drug safety and regulatory writing.
Company Overview
Fortrea is a leading global contract research organization (CRO) specializing in clinical development, medical writing, and pharmacovigilance services. The company partners with pharmaceutical and biotechnology organizations to accelerate drug development and ensure regulatory compliance.
With a strong focus on scientific excellence and operational quality, Fortrea supports global clinical programs and safety monitoring activities across multiple therapeutic areas.
Job Role & Responsibilities
As a Safety Writer, you will be responsible for preparing high-quality safety and regulatory documents for global submissions.
Key Responsibilities:
- Prepare and review aggregate safety reports including PSUR, DSUR, PADER, and risk management plans
- Write and contribute to clinical summaries, CTD documents, and regulatory submissions
- Author subject narratives for adverse drug reactions and serious adverse events
- Conduct literature searches and review scientific data for safety reporting
- Perform benefit-risk evaluation and signal detection reporting
- Review and quality-check documents prepared by junior writers
- Collaborate with cross-functional teams and clients for data collection and inputs
- Prepare medical information responses for healthcare professionals
- Support label updates including CDS, USPI, and SPC documents
- Ensure compliance with pharmacovigilance regulations, ICH-GCP, and SOPs
Eligibility / Qualifications
Educational Background:
B.Pharmacy, M.Pharmacy, Pharm.D, BSc, MSc (Life Sciences, Biotechnology, Microbiology, Biochemistry), Life Sciences
Experience Required:
- Minimum 2–3 years of experience in medical writing or pharmacovigilance
- Experience in safety writing and regulatory documentation preferred
Skills Required:
- Strong scientific writing and data interpretation skills
- Knowledge of pharmacovigilance processes and regulatory requirements
- Excellent written and verbal communication skills
- Strong organizational and time-management abilities
- Proficiency in Microsoft Office tools
Location & Salary
- Location: Mumbai, India
- Job Type: Full-time
- Salary: Competitive salary package based on experience
This role offers excellent growth opportunities in medical writing, drug safety, and regulatory affairs, which are among the most high-paying and globally in-demand career paths in the pharmaceutical industry.
Application Process
Interested candidates can apply through the official Fortrea careers portal:
Apply Here: https://fortrea.wd1.myworkdayjobs.com/Fortrea/job/Mumbai/Safety-Writer_261164
Application Deadline: March 23, 2026
Candidates are encouraged to apply early due to limited openings.
Why This Role Matters in Healthcare
Safety Writers play a critical role in ensuring that drug safety data is accurately documented and communicated to regulatory authorities. Their work directly impacts patient safety, regulatory approvals, and the successful monitoring of pharmaceutical products.
This role contributes to improving global healthcare outcomes by ensuring safe and effective use of medicines.
Frequently Asked Questions (FAQs)
1. Is this role suitable for freshers?
No, this role requires at least 2–3 years of experience in medical writing or pharmacovigilance.
2. What reports will I work on?
You will work on PSUR, DSUR, PADER, risk management plans, and other regulatory safety documents.
3. Is pharmacovigilance knowledge required?
Yes, a strong understanding of pharmacovigilance and safety reporting is required.
4. What career growth can I expect?
You can grow into roles such as Senior Medical Writer, Safety Scientist, or Regulatory Writing Lead.
Summary
| Category | Details |
|---|---|
| Company | Fortrea |
| Vacancies | Safety Writer |
| Required Education | B.Pharmacy, M.Pharmacy, Pharm.D, BSc, MSc, Life Sciences |
| Experience | 2–3 years |
To apply for this job please visit fortrea.wd1.myworkdayjobs.com.
