Fortrea is a leading global contract research organization (CRO) that provides comprehensive clinical development and patient access solutions to pharmaceutical, biotechnology, and medical device companies. With a commitment to scientific excellence and regulatory compliance, Fortrea plays a crucial role in advancing healthcare innovations worldwide.
Job Overview
As a Safety Physician at Fortrea, you will provide medical safety expertise for post-marketing surveillance of drugs, devices, and combination products. You will ensure compliance with pharmacovigilance regulations while maintaining high-quality case processing and medical reviews.
Key Responsibilities
✔ Primary Medical Review: Assess cases for seriousness, causality, labeling, adverse event coding, and narrative accuracy.
✔ Case Documentation: Update and track case data in relevant tools to ensure workflow efficiency.
✔ Quality Assurance: Perform secondary medical reviews (QC/QA) after 1+ year of tenure to identify trends and training needs.
✔ Signal Detection: Conduct aggregate medical reviews and signal analysis as required.
✔ Training & Guidance: Mentor case processing teams on medical aspects after gaining sufficient experience.
✔ Client Relations: Enhance client relationships and maintain a customer-centric approach.
✔ Process Improvement: Contribute to optimizing pharmacovigilance processes.
Qualifications & Experience
Minimum Requirements:
- Education:Â MBBS, MD, DO, or equivalent medical degree.
- Experience:
- Working knowledge of medical sciences, diagnosis, and therapeutics.
- Understanding of ICH-GCP guidelines and regulatory requirements in clinical research.
- Language Proficiency:
- Speaking: English (ILR Level 3+)
- Writing/Reading: English (ILR Level 4+)
Preferred Qualifications:
- 1-2 years of clinical practice experience.
- Up to 1 year of pharmacovigilance (case processing/medical review) or clinical research experience.
- Strong understanding of pharmacovigilance regulations.
Work Environment
- Office or Home-Based: Flexible as per the line manager’s discretion.
How to Apply
