Medical Device Safety Associate

Why consider this job opportunity

• Opportunity for career advancement and growth within a leading organization in the medical device industry
• Flexible work environment with the option to work onsite or remotely
• Engaging and collaborative company culture focused on innovation and customer experience
• Supportive team atmosphere with mentorship opportunities for less experienced staff
• Involvement in impactful projects that enhance global healthcare and patient safety

• Monitor and improve processes related to Individual Case Safety Reports (ICSRs), Clinical Events Committees (CECs), and Data Monitoring Committees (DMCs)
• Perform intake, review, analysis, and data entry of ICSSs, including writing narratives and ensuring compliance with reporting requirements
• Develop and maintain Standard Operating Procedures, guidelines, templates, and training materials for the Safety department
• Participate in departmental quality control activities and assist in quality assurance audits
• Act as coordinator for CEC and DMC, managing documentation, scheduling, and meeting moderation

• Bachelor's degree in Life Sciences or related field; or RN diploma
• Minimum of 1 year of experience in CEC, DMC, Safety reporting, and/or ICSR case processing, or relevant clinical research experience
• Strong knowledge of industry terminology and acronyms
• Excellent verbal and written communication skills with strong attention to detail
• Proficiency in Microsoft Office and ability to learn various software applications

• Experience with Electronic Data Capture (EDC) systems and Safety databases
• Demonstrated organizational and time management skills, with a proactive and professional demeanor
• Ability to work collaboratively in a team environment and effectively manage multiple tasks

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