Fortrea Hiring Safety Writer | Medical Writing Jobs in Pharmacovigilance
- Fortrea Hiring Safety Writer in Mumbai | Medical Writing Jobs in Pharmacovigilance
- Company Overview
- Job Role & Responsibilities
- Eligibility / Qualifications
- Skills Required:
- Experience:
- Location & Salary
- Application Process
- Frequently Asked Questions (FAQs)
- Is this role suitable for freshers?
- What kind of documents will I work on?
- Is clinical research experience required?
- What is the career growth in this role?
- Is advanced degree mandatory?
Fortrea Hiring Safety Writer in Mumbai | Medical Writing Jobs in Pharmacovigilance
Fortrea is hiring experienced professionals for the Safety Writer role in Mumbai. This is a full-time opportunity in the pharmacovigilance and medical writing department, ideal for candidates with a strong background in clinical research, drug safety, and regulatory writing. The company is offering multiple opportunities for skilled professionals who want to build a career in safety writing, regulatory documentation, and global drug safety reporting.
This role is best suited for candidates with prior experience in medical writing or pharmacovigilance who are looking to work on global safety reports and regulatory submissions.
Company Overview
Fortrea is a globally recognized contract research organization (CRO) providing clinical development, patient access, and technology solutions to pharmaceutical and biotechnology companies. The organization plays a key role in supporting drug development through clinical trials, safety monitoring, and regulatory compliance.
With a strong reputation in clinical research and pharmacovigilance services, Fortrea offers professionals the opportunity to work on high-impact global healthcare projects, contributing directly to drug safety, risk management, and patient well-being.
Job Role & Responsibilities
As a Safety Writer, you will be responsible for preparing, reviewing, and managing a wide range of pharmacovigilance and regulatory documents. This role focuses on high-quality scientific writing, safety data analysis, and regulatory compliance for global submissions.
Key responsibilities include:
- Prepare and review aggregate safety reports and risk management documents
- Author periodic safety reports such as PSUR, PADER, DSUR, and IND annual reports
- Contribute to risk management plans and benefit-risk evaluation documents
- Write clinical summaries and Common Technical Document (CTD) sections
- Develop adverse event narratives and safety issue analysis reports
- Perform quality review of documents prepared by junior medical writers
- Conduct scientific literature searches and prepare summaries for safety evaluation
- Collaborate with cross-functional teams and clients for data collection and report development
- Participate in label updates including core data sheets and prescribing information
- Support signal detection activities and pharmacovigilance assessments
- Ensure all deliverables meet regulatory requirements and timelines
This role plays a crucial part in ensuring drug safety, regulatory compliance, and successful submission of safety data to global health authorities.
Eligibility / Qualifications
Candidates must meet the following educational requirements:
BSc Life Sciences, MSc Life Sciences, Pharmacy, Pharmacology, Biotechnology, Microbiology, Biochemistry, Clinical Research, Medicine, Life Science related disciplines
Skills Required:
- Strong expertise in medical writing and pharmacovigilance
- Knowledge of ICH-GCP guidelines and global regulatory requirements
- Excellent scientific writing and documentation skills
- Proficiency in Microsoft Office tools
- Strong analytical and critical thinking abilities
- Effective communication and stakeholder coordination skills
Experience:
- Minimum 3 years in pharmaceutical industry OR
- At least 2 years of experience in medical writing
Location & Salary
- Location: Mumbai
- Salary: Competitive salary package as per CRO and pharmacovigilance industry standards
Application Process
Interested candidates can apply directly through the official Fortrea careers portal:
Apply Here: https://fortrea.wd1.myworkdayjobs.com/Fortrea/job/Mumbai/Safety-Writer_261164
Early applications are recommended as positions may close once suitable candidates are selected.
Frequently Asked Questions (FAQs)
Is this role suitable for freshers?
No, prior experience in medical writing or pharmacovigilance is required.
What kind of documents will I work on?
You will work on safety reports such as PSUR, DSUR, PADER, risk management plans, and regulatory submissions.
Is clinical research experience required?
Yes, candidates with clinical research or pharmacovigilance experience are preferred.
What is the career growth in this role?
You can progress to Senior Medical Writer, Safety Lead, or Regulatory Writing roles.
Is advanced degree mandatory?
No, but a Master’s or PhD is preferred and can enhance career growth.
| Category | Details |
|---|---|
| Company | Fortrea |
| Vacancies | Safety Writer (Medical Writing / Pharmacovigilance) |
| Required Education | BSc Life Sciences, MSc Life Sciences, Pharmacy, Pharmacology, Biotechnology, Microbiology, Biochemistry, Clinical Research, Medicine |
| Experience | 2–3 Years |
To apply for this job please visit fortrea.wd1.myworkdayjobs.com.
