Medical Physician Specialist I

Role & Responsibilities
• Perform primary medical review of safety cases, including assessment of seriousness, listedness/labeling, causality, adverse event coding, and medical narrative review
• Update and document daily case data and case feedback in designated trackers and workflow management tools
• Take full ownership of assigned deliverables while meeting quality, compliance, productivity SLAs, and KPIs
• Provide medical guidance and training to case processing teams after completion of one year of tenure
• Support aggregate review and signal detection activities related to single case processing
• Ensure high standards of customer service and contribute to a culture of quality and accountability

Qualifications
• Bachelor’s degree in Medical Sciences OR MD / DO or equivalent medical degree
• Relevant and equivalent experience may be considered in lieu of formal education

Language Requirements
• Speaking: English – ILR Level 3+ or higher
• Reading/Writing: English – ILR Level 4+ or higher

Experience
• Working knowledge of medical sciences, diagnosis, therapeutics, drug treatments, and clinical procedures
• Understanding of regulatory requirements related to Clinical Research
• Knowledge of ICH-GCP guidelines

Preferred Qualifications
• 1–2 years of clinical practice experience

Skills
• Pharmacovigilance and ICSR processing
• Medical case review and safety assessment
• Adverse event coding and narrative writing
• Signal detection and aggregate review
• Regulatory compliance (ICH-GCP)
• Clinical research knowledge
• Documentation and workflow management
• Communication and training skills

About the Company
• Fortrea is a global Contract Research Organization (CRO) delivering clinical development, patient access, and pharmacovigilance solutions to biopharmaceutical and medical device companies worldwide