RN Licensed Medical Safety Reviewer

Job Summary

To support clinical trial safety surveillance, the remote Medical Safety Reviewer II will review clinical safety data, assess adverse events, and ensure compliance with regulatory requirements while working on a 2-year contract basis.

Key responsibilities

• Review clinical trial safety data through Electronic Data Capture (EDC) systems, including adverse events and laboratory results
• Assess adverse event data for clinical significance and prepare safety narratives and reports
• Identify potential safety signals and communicate findings to Study Leads and clinical safety teams

Required qualifications

• Bachelor's degree in Nursing, Pharmacy, or a related healthcare/science discipline required
• Minimum 2 years of direct bedside patient care experience
• Active RN or Pharmacist licensure, as applicable to the candidate's clinical background
• Experience reviewing adverse events and clinical safety data
• Knowledge of ICH, FDA, and EMA safety regulations and clinical study protocols