Quality Assurance Specialist, SDV​/SDEA

Base pay range

$46,000.00/yr - $54,000.00/yr

This role is responsible for reviewing data from all channels of communication specific to clients source data verification (SDV) / safety data exchange agreement (SDEA) requirements for any potential Adverse Events (AE), Product Quality Complaints (PQC), or Medical Inquiries (MI) to ensure that they have been correctly reported per requirements. Within this role, the SDV/SDEA Quality Assurance Team Lead serves customers by identifying, analyzing, and reporting on AE, PQC, and MI data received by Assist Rx.

The SDV/SDEA Quality Assurance Team Lead regularly supports department managers and directors to effectively maintain quality program operations and goals.

• 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  (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

• Previous call center experience participating in quality call and system audit performance reviews preferred
• Previous experience in patient support/patient assistance and/or financial access programs preferred
• Knowledge of AE/PQC/MI reporting practices
• Bilingual - Spanish preferred
• Bachelor's degree a plus

Health:
Medical, dental, vision, life, & short-term disability insurance
Wellness:
Tele Doc services for those enrolled in medical insurance
Work‑life:
Preloaded PTO of 100 hours (12.5 days) upon employment, increasing to 140 hours (17.5 days) after anniversary; tenure vacation bonus ($1,000 at 3‑year anniversary, $2,500 at 5‑year anniversary)
Flexibility:
Opportunity to work a hybrid schedule after 120 days post‑training
Career Growth:
Promote from within mentality;
Advance Gold program for skill and career development
Compensation:
Competitive pay structure, matching 401(k) with immediate vesting
Recognition:
Quarterly awards (#Transforming Lives Honor, Values Award) and annual Vision Award
Culture:
Supportive, progressive, fast‑paced environment; inclusive & diverse culture

Assist Rx, Inc. is proud to be an Equal Opportunity Employer. All qualified applicants will receive consideration without regard to race, religion, color, sex (including pregnancy, gender identity, and sexual orientation), parental status, national origin, age, disability, family medical history or genetic information, political affiliation, military service, or any other non‑merit based factors, or any other protected categories protected by federal, state, or local laws.

All offers of employment with Assist Rx are conditional on a successful pre‑employment background check and verification of identity and eligibility to work in the United States. Sponsorship and/or work authorization is not available for this position. Assist Rx does not accept unsolicited resumes from search firms or other vendor services; any unsolicited resumes will be considered property of Assist Rx and no fee will be paid in the event of a hire.