Senior Safety Associate

Job Summary

A company is looking for a Senior Medical Device Safety Associate.

Key Responsibilities:

• Monitoring and improving processes related to management of Individual Case Safety Reports, Clinical Events Committees, and Data Monitoring Committees
• Performing intake, review, analysis, and data entry of ICSRs into tracking system
• Providing content for the development and maintenance of 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 3 years' experience in CEC, DMC, Safety reporting, or ICSR case processing preferred
• Expertise in MedDRA coding and use in EDC database and Safety database
• Maintains knowledge of medical terminology and industry acronyms
• Proficient with Microsoft Office and various software applications