Quality Assurance Specialist, SDV/SDEA

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Hiring Remotely in Orlando, FL, USA
In-Office or Remote
Information Technology
The Role

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.

DUTIES AND 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.

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.

Benefits

About AssistRx: Voted Top Work Places in Orlando 3 years in a row, AssistRx understands that the key to success is our fantastic team members. AssistRx has engineered the perfect blend of technology and talent to deliver best in class results. We believe that access to specialty therapies transforms lives and is achieved through the powerful combination of our people and technology. Want to know more? Follow us on  to find out how our team members are #TransformingLives.

Why Choose AssistRx:

    • 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!

Want to learn more about what employee benefits AssistRx offers? Here are some additional benefits that our employees enjoy!

    • 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

Wondering how we recognize our employees for delivering best in class results? Here are some of the awards that our employees receive throughout the year!

    • #TransformingLives Honor: This quarterly award program is a peer to peer honor that recognizes and highlights some of the amazing ways that our team members are transforming lives for patients on a daily basis.
    • Values Award: This quarterly award program recognizes individuals who exhibit one, or many, of our core company values; Excellence, Winning, Respect, Inspiration, and Teamwork.
    • Vision Award: This annual award program recognizes an individual who has gone above and beyond to support the AssistRx vision to transform lives through access to therapy.

AssistRx, 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 other non-merit based factors, or any other protected categories protected by federal, state, or local laws.

All offers of employment with AssistRx are conditional based on the successful completion of a pre-employment background check.

In compliance with federal law, all persons hired will be required to verify identity and eligibility to work in the United States and to complete the required employment eligibility verification document form upon hire. Sponsorship and/or work authorization is not available for this position.

AssistRx does not accept unsolicited resumes from search firms or any other vendor services. Any unsolicited resumes will be considered property of AssistRx and no fee will be paid in the event of a hire

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The Company
Des Moines, IA
353 Employees
Year Founded: 2009

What We Do

AssistRx has engineered the perfect blend of technology and talent to provide manufacturers with an intelligent therapy initiation and patient support solution that improves patient uptake, visibility and outcomes. Our balanced approach streamlines enrollment, reduces therapy disruptions and provides real-time therapy visibility through an integrated solution—delivering the informed touchpoints that simplify a complex system to enable better results for today’s patients. The AssistRx solution includes therapy initiation and patient support, patient education and adherence, and therapy insights and analytics. We have built our entire platform to be flexible and scalable—interoperable with today’s technology standards. As the only independent provider of an integrated solution, we offer the dual benefit of a stable, mature company that delivers with the nimble, responsive attitude of an entrepreneurial team. Experience what intelligent specialty therapy initiation and patient support is truly about—with the perfect blend of technology and talent that only AssistRx can deliver.

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