Safety Associate

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NAMSA

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

Founded 1967

🏥 Healthcare

🏭 Manufacturing

📦 Logistics

Healthcare • Manufacturing • Logistics

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

• Promote operational excellence by monitoring and improving processes for ICSRs, CECs, and DMCs • Intake, review, analyze, and enter ICSR data into tracking, regulatory reporting, and Safety database systems • Write ICSR narratives and interpret medical conditions, laboratory results, and medical procedures • Determine follow-up data required for ICSR completion and distribute ICSR notifications to study teams and Sponsors • Participate in ICSR reconciliation between Clinical and Safety databases • Use MedDRA for term coding • Develop and maintain Safety department SOPs, guidelines, templates, and training materials • Establish work priorities independently and maintain departmental performance and quality metric tracking tools • Attend study team and company meetings, provide status updates, and track action items • Assist with quality assurance activities, including audits • Maintain knowledge of Good Clinical Practices, Good Vigilance Practices, Safety writing practices, and data-entry conventions • Mentor and coach less experienced Safety team members and non-Safety staff • Co-author study-specific Safety project documents and ensure compliance • Maintain knowledge of study protocol sections related to Safety services • Participate in design, testing, and maintenance/use of electronic systems supporting CEC, AE Reporting, and Safety services • Use Electronic Data Capture and Safety Database systems for data entry, AE review, and query creation/resolution • Collaborate with Sponsors and internal departments to ensure data quality and accuracy • Participate in departmental quality control activities • Act as CEC coordinator, including member documentation, contracts, adjudication tracking, and document packages • Act as DMC coordinator, including member documentation, contracts, meeting scheduling/moderation, and action-item/minute documentation • Maintain knowledge of Safety services in work orders and assist with invoicing and billing issues • Prepare aggregate Safety reports and submit final reports to Regulatory Authorities or Sponsors • Assist with Trial Master File maintenance for Safety-related documentation • Perform additional related work as assigned by Management

🎯 Requirements

• Bachelor's degree from a four-year college or university in Life Sciences or related field; or RN diploma • At least 1 years’ experience in CEC, DMC, Safety reporting, and/or ICSR case processing preferred, or Medical Degree, RN, PharmD with clinical research experience • Experience using EDC database and/or Safety database required • Strong knowledge of industry acronyms and medical terminology • Demonstrated organizational and time-management skills • Proactive 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, accuracy, tact, judgment, and discretion • Proficient with Microsoft Office, including Outlook, Word, and Excel • Proficient in learning and utilizing software applications and computerized systems, including Electronic Data Capture systems and project management tools • Ability to perform basic searches via the internet or comparable data repositories • Travel not expected • Extensive computer keyboard use and ability to perform the stated physical duties, with reasonable accommodations available

🏖️ Benefits

• Remote work option • Onsite work option • Equal employment opportunity • Pre-employment background and drug screen processes aligned to local, state and federal laws