Safety Associate

Role Overview:

• This remote role supports the delivery of high-quality safety services across clinical research and medical device programs.
• You will contribute to the accurate management, review, analysis, and reporting of individual case safety reports and clinical safety data.
• The position also supports Clinical Events Committees (CECs), Data Monitoring Committees (DMCs), and related study safety activities.

Key Accountabilities:

• Manage the intake, review, analysis, coding, and data entry of Individual Case Safety Reports (ICSRs), including adverse events and device deficiencies.
• Prepare ICSR narratives, interpret medical information, and coordinate case notifications and submission activities.
• Support CEC and DMC activities, co-author safety documents, and prepare aggregate safety reports.

Candidate Profile:

• Bachelor's degree in Life Sciences or related field, or RN diploma; Medical Degree, RN, or PharmD with relevant clinical research experience considered.
• At least 1 year of experience in CEC coordination, DMC activities, safety reporting, or ICSR case processing preferred; experience with EDC and safety databases required.
• Strong knowledge of medical terminology, GCP, GVP, and excellent organizational and communication skills.