Responsibilities
• Provide the medical and clinical expertise needed to perform medical review of Individual Case Safety Report (ICSR)
• Serve as safety medical expert to evaluate ICDRS for all company products either marketed or in clinical development
• Perform regular medical case review for all reported IC SDRs from any source including clinical trials, literature, post‑marketing studies and post‑marketing spontaneous adverse event reports
• Review all AEs and SAEs and determine whether the events are accurately reported and captured as what occurred in patient clinically and confirm that events are correctly coded with MedDRA and confirm seriousness criteria
• Assess AE and SAE expectedness for each event per Reference Safety Information (RSI) and ensure correct, consistent interpretation and application to IC SDRs
• Provide overall case assessment and pharmacovigilance comments on IC SDRs as needed
• Identify important/critical cases with potential safety signals at single case level
Requirements
• MD, DO, MBBS or other international equivalent
• Medical case review experience and prior biopharmaceutical industry experience preferred
• Minimum of 2‑4 years clinical experience, including training required
• Minimum of 8‑10 years pharmacovigilance experience preferred, including 2‑3 years as a Medical Safety Review Physician; other MD experience in the pharmaceutical industry may be considered
• Excellent communication skills (verbal and writing); clear and confident presentation skills
