Apply on Employer Site

AssistRx · 1 day ago

Quality Assurance Specialist, SDV/SDEA

United States

Full-time

Remote

Mid Level

AssistRx is a growing organization that provides life sciences companies with efficient solutions to improve patient outcomes. The Quality Assurance Specialist is responsible for reviewing client source data verification and safety data exchange agreement requirements to ensure accurate reporting of adverse events, product quality complaints, and medical inquiries.

Health CareInformation Technology

H1B Sponsor Likely

Responsibilities

Thoroughly review all forms of communication for client programs for any AE/PQC/MIs

Review program specific CRM to ensure AE/PQC/MIs have been reported and have a Vendor ID (confirmation number) indicating that client teams were notified

Prepare reports as required, indicating findings of SDV/SDEA investigations

Identify reporting trends and collaborate with management to ensure and promote adherence to Patient Solutions and support guidelines within assigned areas

Subject matter expert (SME) for all aspects of SDV/SDEA reporting requirements, across all programs

Determine areas of concern as well as opportunities to streamline processes and eliminate errors

Upon notification of program enhancements, assist with developing associate training materials and participate in training sessions, ensuring associates understand how the program enhancement will impact the quality review/score

Monitor program AEs and present findings to management for immediate review and reconciliation

Provide periodic departmental audit support to program teams and compliance partners

Additional responsibilities as needed based on department, program, and project requirements

Qualification

SDV/SDEA expertiseAdverse Events reportingQuality AssuranceData analysisTraining developmentCommunication skills

Required