Product Complaint Intake Specialist
3 days ago
United Therapeutics is seeking a highly skilled Product Complaint Intake Specialist to join our team. As a key member of our regulatory compliance team, you will be responsible for coordinating and managing processes related to product complaint data collection, ensuring robust and efficient processes are in place for product safety benefit risk management.
Key Responsibilities- Support the overall process and evaluation of regulatory changes to ensure the effectiveness and efficiency of processes for the Product Complaint Intake function.
- Assist in providing quality and compliance oversight for designated vendors and associated workflows, including product complaint handling, investigations, and reporting.
- Provide training and education to colleagues on product complaint handling and user issues, utilizing medical expertise to create and provide training materials.
- Remain current on global regulations, guidelines, and industry best practices for end-to-end case management and ensure compliance with global regulations and guidelines.
- Coordinate product complaints and returns processing, collaborating with QA teams to achieve timely closure of PCs.
- Interface with external and internal groups, including patients, pharmacists, and physicians, regarding complaint information necessary for proper investigation.
- Bachelor's degree in a scientific field preferred.
- 2+ years of relevant experience in product complaint handling, regulatory compliance, or a related field.
- Working knowledge of GMP and product complaint handling regulations and guidance.
- Proficient computer skills, including software and hardware skills in a network environment.
- Ability to make sound and independent decisions on product complaint concerns/issues specific to triage and severity.
- Strong attention to detail and organizational skills.
- Excellent verbal and written communication skills.
- Registered Nurse (RN) certification.
United Therapeutics is a leader in the development of novel pharmaceutical therapies and technologies that expand the availability of transplantable organs. Our mission is to provide a brighter future for patients through the development of life-saving medicines and technologies. We are a founder-led company, relentless in our pursuit of medicines for life.
We offer a comprehensive benefits suite of programs, including medical, dental, vision, prescription coverage, employee wellness resources, savings plans, paid time off, and more. For additional information on Company benefits, please visit our website.
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