Medical Reviewer II

Job Summary

A company is looking for a Medical Reviewer/Safety Reviewer II.

Key Responsibilities

• Assess clinical trial data and participate in safety surveillance activities
• Review safety-related data for content, quality, and adherence to regulatory guidance
• Provide medical support including adverse event reporting and medical communication

Required Qualifications

• Bachelor's degree with a related health science background; RN or clinical pharmacy experience preferred
• Minimum of 2 years of clinical practice experience; 1 year of drug safety experience preferred
• Strong critical thinking skills for data assessment
• Proficiency in computers (Windows, Word, Excel)
• Current knowledge of ICH, FDA, and EMA regulatory guidance related to safety surveillance