Fortrea is a leading global contract research organization (CRO) committed to advancing healthcare through innovative clinical development and safety solutions. With a strong focus on pharmacovigilance and drug safety, Fortrea collaborates with pharmaceutical, biotechnology, and medical device companies to ensure patient safety and regulatory compliance.
Join a dynamic team dedicated to improving patient outcomes while working on cutting-edge clinical trials and post-marketing surveillance.
Job Description
Key Responsibilities:
As a Senior Safety Science Specialist, you will manage adverse event (AE) reporting, ensuring compliance with global pharmacovigilance regulations. Your role includes:
✔ Adverse Event Management:
- Process spontaneous and clinical trial adverse event reports.
- Perform data entry into safety databases, ensuring accuracy and completeness.
- Review AE reports for expedited reporting compliance.
- Write patient narratives and code AEs using MedDRA.
- Determine listedness against product labels (for marketed products).
✔ Regulatory & Compliance Reporting:
- Submit Serious Adverse Event (SAE) reports to regulatory authorities, ethics committees, and clients within required timelines.
- Handle Expedited Safety Reports (ESRs) and Periodic Safety Reports (PSRs) like PSURs, DSURs, and IND reports.
- Conduct database reconciliation with Data Management teams.
✔ Quality & Training:
- Perform peer reviews of safety reports and support trend analysis.
- Mentor junior safety staff in case handling and pharmacovigilance processes.
- Ensure compliance with SOPs, Work Instructions (WI), and safety management plans.
✔ Cross-functional Collaboration:
- Participate in signal detection, trend analysis, and risk assessment.
- Assist in audits, inspections, and CAPA implementation.
- Support Drug Safety Monitoring Boards (DSMBs) and endpoint committees.
Qualifications & Experience
- Bachelor’s/Master’s degree in Pharmacy, Life Sciences, Nursing, or related field.
- 3+ years of experience in pharmacovigilance/drug safety.
- Hands-on experience with clinical trial cases, spontaneous reports, and post-marketing surveillance (PMS).
- Knowledge of LAM (Local Affiliate Monitoring) cases is a plus.
- Proficiency in MedDRA coding and safety databases (e.g., ARGUS, ARISg, Veeva).
- Strong understanding of ICH-GCP, FDA, EMA, and global PV regulations.
Why Join Fortrea?
✅ Work with a global leader in clinical research & pharmacovigilance.
✅ Career growth opportunities in drug safety and regulatory compliance.
✅ Collaborative and innovation-driven work environment.
✅ Competitive salary and benefits.
How to Apply
📌 Last Date: May 24, 2025
