Fortrea is a leading global contract research organization (CRO) committed to providing comprehensive clinical development and patient access solutions to biopharmaceutical and medical device companies. With a strong focus on innovation, compliance, and patient safety, Fortrea plays a crucial role in advancing healthcare through rigorous pharmacovigilance and clinical research.
Join a dynamic team where your expertise in drug safety and pharmacovigilance will contribute to improving patient outcomes worldwide.
Job Description
Key Responsibilities:
Adverse Event Management
- Receive, process, and manage adverse event (AE) reports from clinical trials and spontaneous sources.
- Perform data entry of safety information into adverse event databases.
- Review AE reports for accuracy, completeness, and expedited reporting requirements.
- Write patient narratives and code adverse events using MedDRA.
- Assess listedness against product labels (for marketed products).
- Identify missing clinical data and follow up for additional information.
- Ensure timely medical review of cases.
Regulatory & Compliance Reporting
- Prepare and submit expedited Serious Adverse Event (SAE) reports to regulatory authorities, ethics committees, investigators, and clients within required timelines.
- Assist in database reconciliation with Data Management teams.
- Manage Expedited Safety Reports (ESRs) and Periodic Safety Reports (PSRs).
- Maintain tracking systems and project documentation.
Quality & Process Improvement
- Conduct quality reviews of processed reports and identify trends.
- Support root cause analysis and CAPA (Corrective and Preventive Action) plans.
- Assist in audits, inspections, and compliance-related activities.
Cross-functional Collaboration
- Support safety committees (e.g., DSMBs โ Data Safety Monitoring Boards).
- Assist in client meetings and maintain strong relationships with stakeholders.
- Contribute to the preparation and archiving of safety study files.
Qualifications & Skills
- Bachelorโs or Masterโs degree in Pharmacy, Life Sciences, Nursing, or related field.
- Prior experience in pharmacovigilance, drug safety, or clinical research preferred.
- Strong knowledge of MedDRA coding, ICH-GCP, and regulatory reporting guidelines.
- Excellent attention to detail and ability to manage multiple deadlines.
- Proficiency in safety databases (e.g., Argus, ARISg, Veeva) is a plus.
- Strong written and verbal communication skills.
Why Join Fortrea?
- Work with a global leader in clinical research and pharmacovigilance.
- Opportunity to contribute to patient safety and regulatory compliance.
- Collaborative and growth-oriented work environment.
- Competitive salary and benefits.
How to Apply
If you meet the qualifications and are passionate about drug safety, apply before theย July 4, 2025 deadline.
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