Fortrea is a leading global Contract Research Organization (CRO) providing comprehensive clinical trial and patient safety solutions to pharmaceutical, biotech, and medical device companies. With a strong focus on regulatory compliance, drug safety, and pharmacovigilance, Fortrea plays a crucial role in ensuring patient safety and data integrity across clinical trials and post-market surveillance.
📍 Location: Pune, India (Full-time, On-site)
Detailed Job Description
Key Responsibilities:
✔ Expedited & Periodic Safety Reporting:
- Process Expedited Safety Reports (ESRs) and Periodic Safety Reports (PSRs).
- Maintain adverse event tracking systems and ensure timely submissions to regulatory agencies.
✔ Adverse Event (AE/SAE) Management:
- Log and process AE/SAE reports into tracking systems.
- Write patient narratives and code events using MedDRA.
- Perform listedness assessments (for marketed products).
✔ Regulatory & Compliance Support:
- Ensure compliance with ICH-GCP, FDA, EMA, and other pharmacovigilance regulations.
- Assist in database reconciliation and quality checks.
✔ Team Collaboration & Training:
- Provide peer/quality reviews and mentor junior staff.
- Coordinate with cross-functional teams for safety data management.
✔ Documentation & Administrative Tasks:
- Maintain study files, safety databases, and regulatory documents.
- Schedule meetings and support safety operations as needed.
Eligibility & Qualifications
Education:
- PharmD / MPharm / BPharm (Preferred)
- Nursing / Medical / Life Sciences graduates with relevant experience may apply.
Experience:
✅ 2+ years in pharmacovigilance, drug safety, or clinical research.
✅ Experience in AE/SAE processing, MedDRA coding, and regulatory submissions.
✅ Background in pharma, biotech, or CROs (preferred).
Skills Required:
🔹 Attention to detail & strong analytical skills.
🔹 Proficiency in MS Office & safety databases.
🔹 Excellent English communication (written & verbal).
Benefits & Work Environment
✔ Competitive salary & growth opportunities.
✔ Hybrid/On-site work model (Pune-based).
✔ Global exposure in pharmacovigilance & clinical safety.
✔ Training & mentorship from industry experts.
How to Apply?
