Product Complaint Intake Specialist

5 days ago

Durham, North Carolina, United States United Therapeutics Full time
About the Role

We are seeking a highly skilled Product Complaint Intake Specialist to join our team at United Therapeutics. As a Product Complaint Intake Specialist, you will be responsible for coordinating and managing processes governing robust product complaint data collection for UTC products. This includes ensuring robust, efficient processes are in place for proper product complaint intake and triage, returned goods authorizations, medical device reporting, and/or field alert reports.

Key Responsibilities
  • Coordinate product complaints and returns processing and collaborate with QA team to achieve the timely closure of the PCs
  • Interface/act as point of contact with external and internal groups, including but not limited to patients, pharmacists, and/or physicians regarding the complaint information necessary for proper investigation
  • Perform routine review/quality checks of activities outsourced to UT GPS Designated Vendor regarding product complaint triage and product complaint assessments
  • Act as point of contact for day-to-day questions or issue escalation for all product complaint handling safety processes for internal stakeholder (i.e. PSRMMT, quality, regulatory, etc.), vendor(s), and/or external partners
  • Perform reconciliation of PCs assessed for investigation & initiation of investigation by quality or third party in accordance with the internal procedures or in compliance with applicable pharmacovigilance agreements (PVAs)
Requirements
  • Bachelor's degree in a scientific field preferred
  • 2+ years of relevant experience
  • Working knowledge of GMP and Product Complaint handling regulations and guidance with ability to interpret and apply new or changing regulations and/or guidance
  • Proficient computer skills and demonstrated competence to include software/hardware skills: word-processing, database applications, and spreadsheets in a network environment
  • Ability to make sound and independent decisions on product complaint concerns/issues specific to triage & severity
  • Strong attention to detail and organizational skills
  • Excellent verbal and written communication skills
  • Must be able to work independently with minimum supervision and as part of a multi-functional team, being able to handle high workloads, stressful situations and deadlines
Preferred Qualifications
  • Registered Nurse (RN)
About United Therapeutics

At United Therapeutics, you'll realize quickly that it is not an ordinary place to work. When you join our company, you will learn, grow, contribute, have fun, and be challenged... all while making a difference in the lives of our patients.

Eligible employees may participate in the Company's comprehensive benefits suite of programs, including medical / dental / vision / prescription coverage, employee wellness resources, savings plans (401k and ESPP), paid time off & paid parental leave benefits, disability benefits, and more. For additional information on Company benefits, please visit

While United Therapeutics does not require vaccination for Covid-19 at this time, we strongly encourage all employees and visitors to remain up to date on vaccinations and boosters to protect one another from illness. Employees working in customer-facing roles must adhere and comply with customers' credentialing guidelines, which may require vaccination against Covid -19, the influenza virus, and other illnesses that could be harmful to healthcare staff and patients.

United Therapeutics Corporation is an Equal Opportunity/Affirmative Action Employer - EOE Minorities / Females / Protected Veterans / Individuals with Disabilities

We strive to be an organization that engages the minds, hearts, and most spirited efforts of each of our employees. Our sense of purpose transforms what we do from work into mission, occupation into vocation and achievement into success.

We challenge our employees with innovative and revolutionary projects, offer an environment which fosters high-level job performance and provide a highly competitive total rewards package. This is what makes United Therapeutics a stimulating place to work.

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