Safety Associate

About the Company

NAMSA pioneered the medical device materials safety industry and was the first independent company in the world to focus solely on medical device materials. Founded before the U.S. Food and Drug Administration began regulating such products in 1976, NAMSA has shaped the industry by developing the test methods that govern it. As the industry’s premier provider, NAMSA supports clients throughout the entire product development lifecycle and beyond.

Our vision is to inspire innovative MedTech solutions that advance global healthcare, improve patient lives, and accelerate client success. Our mission is to deliver best-in-class global MedTech development solutions through our people, expertise, and technology, guided by 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

About the Role

This role promotes 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, as well as Clinical Events Committees (CECs) and Data Monitoring Committees (DMCs).

Responsibilities

• Perform intake, review, analysis, and data entry of ICSRs into tracking systems, regulatory reports, and/or Safety databases
• Write ICSR narratives and interpret reported event information, including medical conditions, laboratory results, and medical procedures
• Determine relevant follow-up data required for ICSR completion
• Distribute notifications of ICSRs to study teams/Sponsors, including case triage and submission requirements
• Participate in ICSR reconciliation between Clinical and Safety databases
• Utilize MedDRA dictionary for term coding
• Contribute to the development and maintenance of Standard Operating Procedures, guidelines, templates, and training materials for the Safety department
• Independently establish work priorities with minimal input from management
• Maintain tracking tools for departmental key performance and quality indicator metrics
• Meet key performance indicators and quality targets established by management
• Attend study team and company staff meetings, providing status updates and tracking action items
• Assist in quality assurance activities, including audits
• Develop and maintain knowledge of current Good Clinical Practices, Good Vigilance Practices, Safety best writing practices, and data entry conventions
• Serve as a mentor and coach to less experienced Safety team members and non-Safety staff
• Co-author study-specific Safety project documents (e.g., Safety Plans, CEC Charters, DMC Charters) based on clinical study protocol details and contracted Safety services
• Ensure compliance with study-specific Safety documents
• Maintain solid knowledge of study protocol sections pertaining to Safety services
• Participate in the design, testing, and/or ongoing maintenance of electronic systems that support CEC, AE Reporting, and other Safety services
• Utilize Electronic Data Capture systems and Safety Databases for data entry, AE review, and query creation/resolution
• Work with Sponsors, departmental peers, or other NAMSA departments to ensure quality and accuracy of data generated through Safety services
• Participate in departmental quality control activities to ensure accuracy of data for study deliverables
• Act as CEC coordinator: gather member documents, develop member contracts, track events for adjudication, and prepare adjudication document packages including narratives
• Act as DMC coordinator: gather member documents, develop member contracts, schedule and moderate meetings, and ensure action items/minutes are completed and documented
• Maintain knowledge of Safety services included in work orders, assist in proper invoicing, and resolve billing issues with Finance
• Prepare aggregate Safety reports and submit final reports to Regulatory Authorities or Sponsors
• Assist project teams with Trial Master File maintenance for Safety-related documentation
• Perform additional related work as required and assigned by management

Requirements

• Bachelor’s degree from a four-year college or university in Life Sciences or a related field; or RN diploma
• At least 1 year of experience in CEC, DMC, Safety reporting, and/or ICSR case processing preferred, or a Medical Degree, RN, or PharmD with clinical research experience
• Experience with EDC and/or Safety databases required
• Strong knowledge of industry acronyms and medical terminology
• Demonstrated organizational and time management skills; proactive with a focus on compliance and responsibilities
• Good verbal and written communication skills
• Excellent interpersonal skills and ability to work collaboratively in a team environment
• High attention to detail, accuracy, tact, judgment, and discretion
• Proficient with Microsoft Office (Outlook, Word, Excel)
• Ability to learn and utilize various software applications, including Electronic Data Capture systems and project management tools
• Ability to perform basic internet searches or use comparable data repositories

Working Conditions

• Travel is not expected
• Duties can be performed onsite or remotely
• Physical activities include sitting for extended periods, occasional standing and walking, and extensive use of a computer keyboard
• Specific vision abilities required: close vision, depth perception, and ability to adjust focus
• Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions

Pay

Compensation target: $75,000.00 annually. The compensation grade range for this position is $56,000.00 – $109,000.00 per year. Individual base pay depends on factors such as role complexity, job duties, relevant experience, skills, and primary work location.