Senior Safety Associate - Medical Device

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.

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.

• May assist in the business development process with potential clients and clients considering expanding services.

• Serves as subject matter expert related to Safety services for Company and Sponsors.

• 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, schedules and moderates meetings, and ensuring action items/minutes are completed and properly documented.

• Maintains knowledge of Safety services included in work orders, assists in proper invoicing and resolving any billing issues with Finance.

• Prepares aggregate Safety reports and submits final reports to Regulatory Authorities or Sponsor.

• May assist project teams with Trial Master File maintenance for Safety-related documentation.

• Performs any additional related work as required and assigned by Management.

Qualifications & Technical Competencies:

Principal Duties and Responsibilities

• 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, schedules and moderates meetings, and ensuring action items/minutes are completed and properly documented.
• Maintains knowledge of Safety services included in work orders, assists in proper invoicing and resolving any billing issues with Finance.
• Prepares aggregate Safety reports and submits final reports to Regulatory Authorities or Sponsor.
• May assist project teams with Trial Master File maintenance for Safety-related documentation.
• Performs any additional related work as required and assigned by Management.

Qualifications and Skills

• 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.

Technical Competencies

• Proficient with Microsoft Office including Outlook, Word, and Excel.
• Proficient in learning/utilizing various software applications and computerized systems including but not limited to Electronic Data Capture systems and project management tools.
• Ability to perform basic searches via the internet or other comparable data repositories.