Senior Safety Associate

🔥 13 hours ago

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NAMSA

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

Founded 1967

⚕️ Healthcare Insurance

🧬 Biotechnology

💊 Pharmaceuticals

Healthcare Insurance • Biotechnology • Pharmaceuticals

NAMSA is a global leader in medical device testing and research, offering comprehensive consulting, preclinical research, clinical research, and testing services for medical device and IVD manufacturers worldwide. With a team of over 1,400 specialists and state-of-the-art labs across North America, Europe, and Asia, NAMSA conducts extensive testing to ensure the safety, efficacy, and compliance of medical devices. The company provides strategic consulting on regulatory submissions and market strategies, helping clients navigate complex regulatory landscapes efficiently and effectively. Founded in 1967, NAMSA is trusted by manufacturers to deliver high-quality services from concept to commercialization.

📋 Description

• Actively works to promote operational excellence by monitoring and improving processes related to management of Individual Case Safety Reports (ICSRs). • 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. • Participates in ICSR reconciliation between Clinical database and Safety database as required. • Provides content for ongoing development and maintenance of Standard Operating Procedures. • Independently establishes work priorities with minimal input from Management. • Maintains tracking tools for departmental key performance/quality indicator metrics. • Attends study team meetings and company staff meetings, providing status updates and tracking action items as needed. • Assists in quality assurance activities including audits. • Serves as mentor and coach to less experienced Safety team members and non-Safety staff.

🎯 Requirements

• Bachelor's degree from a four-year college or university in Life Sciences or related field; or RN diploma. • At least 3 years’ experience in CEC, DMC, Safety reporting, and / or ICSR case processing preferred, or Medical Degree, RN, PharmD with clinical research experience. • Experience and use in EDC database and / or Safety database required. • Strong knowledge of industry acronyms and medical terminology. • Demonstrated organizational skills, time management skills, pro-active, and displays a professional demeanor with focus on compliance and responsibilities. • Good verbal and written communication skills. • Excellent interpersonal skills. • Ability to work collaboratively and effectively in a team environment. • High attention to detail and level of accuracy, tact, judgement, and discretion.

🏖️ Benefits

• Competitive salary • Remote work options