📍 Location: Pune, Maharashtra
🏢 Company: Fortrea
🎯 Position: Safety Science Specialist
🕒 Experience Required: 3–5 Years
🎓 Eligibility: B.Pharm, M.Pharm, Pharm.D, MSc, BSc (Life Sciences)
🗓️ Last Date to Apply: May 4, 2025
🧬 About Fortrea
Fortrea is a globally recognized clinical research and pharmacovigilance company known for delivering life-changing solutions across healthcare. With innovation-driven teams and partnerships with global biopharma, Fortrea plays a vital role in advancing drug development and patient safety.
The company is now inviting applications for the post of Safety Science Specialist at its Pune office—a strategic role focused on pharmacovigilance, regulatory reporting, and compliance monitoring.
🧾 Job Overview: Safety Science Specialist
As a Safety Science Specialist, you will serve a crucial role in monitoring drug safety and managing adverse events arising during clinical trials or post-marketing surveillance. This position requires a well-rounded professional with knowledge in regulatory reporting, MedDRA coding, patient narrative writing, and pharmacovigilance best practices.
If you’re passionate about patient safety, possess deep pharma knowledge, and enjoy working in a high-compliance environment, this role could be your next big career move.
🧪 Key Responsibilities
🔍 1. Adverse Event Management
- Review, analyze, and process adverse event reports from various sources including trials, hospitals, and post-market data
- Ensure completeness and accuracy of data collected from investigators and clinical sites
💻 2. Data Entry and MedDRA Coding
- Input safety information into company-specific adverse event databases
- Apply MedDRA coding to medical terms and classify adverse reactions accurately
- Write detailed patient narratives based on reported events
📑 3. Regulatory Submissions
- Prepare Serious Adverse Event (SAE) reports and Expedited Safety Reports (ESRs)
- Submit regulatory reports to global health authorities, ethics committees, and sponsors within defined timelines
🔄 4. Database Reconciliation
- Work closely with Data Management teams to ensure that clinical and safety databases are in sync
- Participate in query management and reconciliation cycles
📈 5. Reporting and Trend Analysis
- Contribute to Periodic Safety Update Reports (PSURs) and Development Safety Update Reports (DSURs)
- Perform quality review and identify safety trends that require further investigation
🗂️ 6. Documentation and Archiving
- Maintain trial master files, audit-ready project documentation, and SOP-compliant safety archives
- Track status reports and safety compliance metrics
🤝 7. Client Communication
- Participate in client discussions and update them on safety-related deliverables
- Prepare supporting documents for Safety Committees and Data Safety Monitoring Boards (DSMBs)
✅ Eligibility Criteria
| Requirement | Details |
|---|---|
| Education | Bachelor’s or Master’s degree in Life Sciences, Pharmacy, or a related field |
| Experience | 3 to 5 years of work experience in pharmacovigilance or drug safety |
| Skills | MedDRA coding, SAE reporting, narrative writing, ICH-GCP compliance |
| Soft Skills | Strong attention to detail, multitasking, analytical mindset |
| Systems | Familiarity with pharmacovigilance software and regulatory tracking systems |
💼 Why Join Fortrea?
Joining Fortrea means being part of a mission-driven organization that values integrity, innovation, and continuous learning.
Key Benefits:
- 🌍 Global Exposure: Work on safety profiles of international drug pipelines
- 🧠 Challenging Projects: Handle complex safety cases across diverse therapeutic areas
- 📚 Learning Environment: Regular trainings, SOP refreshers, and pharmacovigilance workshops
- 🏥 Work-Life Balance: Structured work hours with remote flexibility where applicable
- 🛡️ Comprehensive Benefits: Includes health insurance, paid leaves, and performance incentives
📊 Role Structure and Work Environment
- On-site role based in Pune, India
- Cross-functional collaboration with Regulatory, Clinical, and Data Management teams
- Structured and audited workflow in compliance with global health regulations
- Frequent client interaction and exposure to international regulatory bodies
🧭 Career Path After This Role
| Level | Career Progression |
|---|---|
| Safety Science Specialist | Entry-Level Specialist Role |
| Safety Manager | Oversee team of specialists, lead safety projects |
| Pharmacovigilance Lead | Strategic oversight of regional/global PV |
| Director – Drug Safety | Manage global safety operations and reporting |
📝 How to Apply
To apply, update your professional CV and prepare a tailored application for the Safety Science Specialist role at Fortrea. Ensure your resume highlights the following:
- MedDRA coding experience
- Regulatory reporting timelines you’ve handled
- Knowledge of pharmacovigilance tools and software
- Projects involving patient narrative writing and SAE management
- Any global health authority interactions (FDA, EMA, etc.)
📌 Mention your years of experience, location preference, and immediate availability clearly in your application.
📌 Recap Snapshot
| Job Title | Safety Science Specialist |
|---|---|
| Company | Fortrea |
| Location | Pune |
| Experience | 3–5 Years |
| Qualification | B.Pharm, M.Pharm, Pharm.D, BSc, MSc |
| Key Skills | Drug safety, MedDRA, Pharmacovigilance regulations |
| Salary | Competitive (based on experience) |
| Deadline | May 4, 2025 |
🧠 Final Note
This job at Fortrea is your chance to work at the frontline of patient safety, handling global responsibilities in pharmacovigilance and regulatory reporting. With a strong foundation in safety science, you can build a fulfilling career protecting lives while working in one of India’s most exciting pharma hubs.
Apply now and take a confident step into global drug safety operations with Fortrea.
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