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. Utilizes MedDRA dictionary for term coding.
•Provides content for the ongoing development and maintenance of Standard Operating Procedures, guidelines, templates, and training materials for Safety department.
•Independently establishes work priorities with minimal input from Management.
•Maintains tracking tools for departmental key performance/quality indicator metrics.
•Meets key performance indicators and quality targets established by Management.
•Attends study team meetings and company staff meetings, providing status updates and tracking action items as needed.
•Assists in quality assurance activities including audits.
•Develops and/or maintains knowledge of current Good Clinical Practices, Good Vigilance Practices, Safety best writing practices, and data entry conventions.
•Serves as mentor and coach to less experienced Safety team members and non-Safety staff.
•Co-Authors study-specific Safety project documents (Safety Plans, CEC Charters, DMC Charters, etc.) based on clinical study protocol details and contracted Safety services. Ensures compliance with these documents.
•Maintains solid knowledge of study protocol sections pertaining to Safety services.
•Participates in the design, testing, and/or ongoing maintenance/use of electronic systems that aide in the execution of CEC, AE Reporting, and other Safety services.
•Utilizes Electronic Data Capture systems and Safety Database for data entry, AE review, query creation/resolution.
•Work with Sponsor, departmental peers, or other departments within NAMSA to ensure quality/accuracy of data generated through Safety services.
•Participates in departmental quality control activities to ensure accuracy of data for study deliverables.
•Acts as CEC coordinator. Gathers member documents, develops member contracts, tracks events for adjudication, prepares adjudication document packages including narratives.
•Acts as DMC coordinator. Gathers member documents, develops member contracts, schedu