Safety Associate

NAMSA pioneered the industry and was the first independent company in the world to focus solely on medical device materials for safety. NAMSA started testing medical devices before the U.S. Food and Drug Administration started regulating such products in 1976. We are shaping the industry. NAMSA has been a key contributor to the development of the test methods that govern our industry. We have become the industry’s premier provider. We provide support for clients during every step of the product development lifecycle and beyond. Come and work for an organization with the: Vision to inspire innovative MedTech solutions that advance global healthcare, improve patient lives and accelerate Client success and the Mission to deliver best-in-class global MedTech development solutions through our people, expertise and technology by adhering to our core Values: Act with integrity in everything we do. Provide best-in-class customer experiences. Develop superior talent and deliver expertise. Respond with agility and provide timely results. Embrace collaboration, diverse perspectives and ideas. Compensation Target: $75,000.00 Job Description: •Actively works to promote operational excellence by monitoring and improving processes related to management of Individual Case Safety Reports (ICSRs) (including Adverse Events, Serious Adverse Events and Device Deficiencies/Events), Clinical Events Committees (CECs), and Data Monitoring Committees (DMCs). •Performs intake, review, analysis, and data entry of ICSRs into tracking system, regulatory report, and/or Safety database. Writes ICSR narratives. Interprets reported event information, including medical conditions, laboratory results, and medical procedures. Correctly determines relevant follow-up data required for ICSR completion. Distributes notifications of ICSR to study team/Sponsor including case triage and submission requirements. Participates in ICSR reconciliation between Clinical database and Safety database as required. Util