Senior Safety Associate

Job Summary

To support safety management activities, the full-time Senior Safety Associate will oversee the management of Individual Case Safety Reports (ICSRs), Clinical Events Committees (CECs), and Data Monitoring Committees (DMCs) while working remotely.

Key responsibilities

• Promote operational excellence by monitoring and improving processes related to ICSR management, CECs, and DMCs
• Perform intake, review, analysis, and data entry of ICSRs, ensuring compliance with reporting requirements
• Develop and maintain Standard Operating Procedures, guidelines, and training materials for the Safety department

Required qualifications

• Bachelor's degree in Life Sciences or related field, or RN diploma
• At least 3 years of experience in CEC, DMC, Safety reporting, or ICSR case processing, or a Medical Degree, RN, or PharmD with clinical research experience
• Strong knowledge of industry acronyms and medical terminology
• Proficient in Microsoft Office and various software applications related to data capture and project management
• Demonstrated organizational and time management skills with a focus on compliance