🩺 Medical Physician Specialist I
Locations: Available in 2 Locations
Category: Clinical
Job ID: 255136
Company: Fortrea
🎯 Job Overview
The Medical Physician Specialist I provides medical safety expertise to sponsors of drugs, devices, and combination products during the post-marketing phase. This role involves comprehensive medical case review, causality assessment, and compliance with pharmacovigilance (PV) standards, ensuring timely, accurate, and high-quality deliverables.
🧠 Key Responsibilities
🔹 Case Review & Medical Assessment
Perform primary medical review of individual case safety reports (ICSRs).
Assess cases for seriousness, listedness/labeling, causality, and medical coding (using MedDRA or equivalent).
Conduct narrative reviews to ensure clinical accuracy and consistency.
🔹 Data Tracking & Documentation
Update and document case data and feedback in designated trackers/tools.
Ensure timely tracking, workflow management, and status reporting for all assigned cases.
🔹 Compliance & Quality
Take full ownership of assigned deliverables, meeting all quality, compliance, and productivity SLAs/KPIs.
Uphold regulatory and organizational standards for case processing and documentation.
🔹 Training & Guidance
After completing 1 year tenure, provide medical training and guidance to the case processing team.
Support the team in understanding clinical nuances and medical aspects of safety reporting.
🔹 Aggregate & Signal Activities
Contribute to aggregate reporting and signal detection/analysis, as needed, in support of single case processing activities.
🔹 Customer Service Excellence
Foster and maintain a high-performance culture focused on customer service, accountability, and collaboration.
🎓 Qualifications
📘 Education
Bachelor’s degree in Medical Science, MD, DO, or equivalent medical degree.
Equivalent relevant experience may be considered in lieu of formal education.
🗣️ Language Proficiency
Speaking: English at ILR Level 3+ or higher (Professional Working Proficiency).
Reading/Writing: English at ILR Level 4+ or higher (Advanced Professional Proficiency).
💼 Experience Requirements
✅ Minimum Required
Working knowledge of medical sciences, diagnosis, therapeutics, and drug treatments.
Understanding of regulatory requirements for Clinical Research.
Familiarity with ICH-GCP guidelines and pharmacovigilance processes.
🌟 Preferred
1–2 years of clinical practice experience (hospital, clinic, or research setting).
🧭 Core Competencies
Strong clinical judgment and analytical reasoning.
In-depth understanding of adverse event assessment.
Ability to work under tight timelines with high accuracy.
Effective communication and collaboration across multidisciplinary teams.
Commitment to quality, compliance, and continuous improvement.
🌍 Work Environment
Work from office or home-based setup (as per line manager direction).
Role may require extended periods of computer-based work and documentation.
⚖️ Equal Employment Opportunity (EEO)
Fortrea is committed to equal opportunity employment and offers reasonable accommodations for applicants with disabilities.
🔗 Learn more: EEO & Accommodations Information
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