Quality Assurance Specialist, SDV/SDEA

AssistRx • Orlando, FL

5h • Hybrid

About The Position

AssistRx has engineered the perfect blend of technology and talent (you) to provide life sciences companies with an efficient solution to improve patient uptake, visibility and outcomes. Our talented team members provide therapy and healthcare system expertise to help patients achieve better results from care.
A growing organization, AssistRx views our people as our strongest asset. Join us as we continue to make a difference....
Overview:
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 AssistRx. The SDV/SDEA Quality Assurance Team Lead regularly supports department managers and directors to effectively maintain quality program operations and goals.

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.

Nice To Haves

• Bachelor’s degree a plus.

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.

Benefits

• Work Hard, Play Hard: Preloaded PTO: 100 hours (12.5 days) PTO upon employment, increasing to 140 hours (17.5 days) upon anniversary. Tenure vacation bonus: $1,000 upon 3-year anniversary and $2,500 upon 5-year anniversary.
• Impactful Work: Join a team that is at the forefront of revolutionizing healthcare by improving patient access to essential medications.
• Flexible Culture: Many associates earn the opportunity to work a hybrid schedule after 120 days after training. Enjoy a flexible and inclusive work culture that values work-life balance and diverse perspectives.
• Career Growth: We prioritize a “promote from within mentality”. We invest in our employees' growth and development via our Advance Gold program, offering opportunities to expand skill sets and advance within the organization.
• Innovation: Contribute to the development of groundbreaking solutions that address complex challenges in the healthcare industry.
• Collaborative Environment: Work alongside talented professionals who are dedicated to collaboration, learning, and pushing the boundaries of what's possible. Tell your friends about us! If hired, receive a $750 referral bonus!
• Medical, dental, vision, life, & short-term disability insurance
• Teledoc services for those enrolled in medical insurance
• Supportive, progressive, fast-paced environment
• Competitive pay structure
• Matching 401(k) with immediate vesting
• Legal insurance

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 501-1,000 employees