To promote operational excellence, the full-time Safety Associate will monitor and improve processes related to Individual Case Safety Reports (ICSRs), perform data entry and analysis, and contribute to the development of Standard Operating Procedures while working remotely. Key responsibilities Monitor and enhance processes for ICSR management, including adverse events and clinical event committees Perform intake, analysis, and data entry of ICSRs, ensuring accurate reporting and compliance with protocols Develop and maintain Standard Operating Procedures and training materials for the Safety department Required qualifications Bachelor's degree in Life Sciences or related field, or RN diploma At least 1 year of experience in CEC, DMC, Safety reporting, or ICSR case processing, or a relevant medical degree with clinical research experience Strong knowledge of medical terminology and industry acronyms Proficiency in Microsoft Office and experience with Electronic Data Capture systems Demonstrated organizational and time management skills with a focus on compliance
Safety Associate • Bayamon, Puerto Rico, United States
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