Senior Safety Associate

NAMSA

Senior Safety Associate managing safety reporting activities for medical devices. Promoting operational excellence in medical safety and compliance reporting.

Posted 6/26/2026full-timeRemote • 🇺🇸 United StatesSenior💰 $68,800 - $133,700 per yearWebsite

About the role

Key responsibilities & impact

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

What you’ll need

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

Comp & perks

Competitive salary
Remote work options

ATS Keywords

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Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools

data entryICSR processingnarrative writingdata analysisquality assuranceauditingmedical terminologyregulatory reportingStandard Operating Procedures developmentkey performance indicator metrics

Soft Skills

organizational skillstime managementproactiveprofessional demeanorverbal communicationwritten communicationinterpersonal skillscollaborationattention to detailjudgment

Certifications

Bachelor's degree in Life SciencesRN diplomaMedical DegreePharmD