Product Complaint Intake Specialist - United Therapeutics
Durham, NC
About the Job
California, US residents click here (https://www.unither.com/docs/UNITHER%20Applicant%20Notice%20-%20%2812-22-23%29%20Final%202.15.24%20Combined%20EN%20and%20French.pdf#page=9) .
The job details are as follows:
What We Do
We build on the strength of our research and development expertise and a distinctive, entrepreneurial culture that encourages diversity, innovation, creativity, sustainability, and, simply, fun. Since inception, our mission has been to find a cure for pulmonary arterial hypertension and other life-threatening diseases. Toward this goal we have successfully gained FDA approval for five medicines, we are always conducting new clinical trials, and we are working to create an unlimited supply of manufactured organs for transplantation.
We are the first publicly-traded biotech or pharmaceutical company to take the form of a public benefit corporation (PBC). Our public benefit purpose is to provide a brighter future for patients through (a) the development of novel pharmaceutical therapies; and (b) technologies that expand the availability of transplantable organs. At the same time, we seek to provide our shareholders with superior financial performance and our communities with earth-sensitive energy utilization.
Our company was founded by an entrepreneur whose daughter was diagnosed with a life-threatening condition. She sought to find treatment options and a cure for her daughter and patients like her. We are founder-led, and relentless in our pursuit of “medicines for life”. We continue to research and develop treatments for cardiovascular and pulmonary diseases, and other orphan diseases.
How you’ll contribute
The Product Complaint Intake Specialist will coordinate, enact, and manage processes governing robust product complaint data collection for UTC products for proper management of product safety benefit risk, including 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. Proactively ensure quality and compliance with the established PC process and share any failure or inconsistencies for resolution or closure with UT Global Product Safety (GPS) Management. This is a hybrid position with 3 days/week in our RTP, NC office and 2 days/week work from home.
+ Support the overall process and evaluation of regulatory changes and strategically ensure the effectiveness and efficiency of processes for the Product Complaint Intake function
+ Assist in providing quality and compliance oversight for the designated vendor and all associated workflows, including but not limited to the product complaint workflows/handling, product complaint investigations, maintaining unified product defect investigation operating procedures, maintaining and monitoring systems to ensure that all product complaint investigations received are appropriately investigated and concluded per the company's complaint handling procedure, potentially reportable MDRs, returned goods authorizations, field alert reports, etc.
+ Assist in providing training and/or education in conjunction with the Brand Safety Lead (BSL) and the product FMEAs for the UT product(s) with respect to potential product complaints or user issues that could be experienced; use medical expertise to create and provide training as well as using medical expertise to make independent medical assessments on qualification of a report meeting MDR reporting or FAR reporting criterion
+ Remain current on global regulations, guidelines and industry best practices for end-to-end case management (SAEs) and ensure compliance with global regulations and guidelines for development/non-development programs relating to product complaint handling, product complaint investigations and reporting MDRs
+ Coordinate the 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
+ Interface/act as point of contact with the Specialty Pharmacies or other 3rd parties suppling return goods authorization for product return for 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)
+ Support and perform as needed all steps specific to intake, data entry, follow-up and investigations for product complaints in accordance with UT policies & procedures
+ Assist with oversight of PC intake activities outsourced to vendors, including training, issue resolution, process updates/enhancements and compliance
+ Perform other duties as assigned
For this role you will need
Minimum 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
+ Experience with Microsoft Office applications (i.e. Word, Excel, PowerPoint, Outlook)
+ Experience with TrackWise, TrackWise Digital or similar product complaint management system
Preferred Qualifications
+ Registered Nurse (RN)
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 https://www.unither.com/careers/benefits-and-amenities
_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._
The job details are as follows:
What We Do
We build on the strength of our research and development expertise and a distinctive, entrepreneurial culture that encourages diversity, innovation, creativity, sustainability, and, simply, fun. Since inception, our mission has been to find a cure for pulmonary arterial hypertension and other life-threatening diseases. Toward this goal we have successfully gained FDA approval for five medicines, we are always conducting new clinical trials, and we are working to create an unlimited supply of manufactured organs for transplantation.
We are the first publicly-traded biotech or pharmaceutical company to take the form of a public benefit corporation (PBC). Our public benefit purpose is to provide a brighter future for patients through (a) the development of novel pharmaceutical therapies; and (b) technologies that expand the availability of transplantable organs. At the same time, we seek to provide our shareholders with superior financial performance and our communities with earth-sensitive energy utilization.
Our company was founded by an entrepreneur whose daughter was diagnosed with a life-threatening condition. She sought to find treatment options and a cure for her daughter and patients like her. We are founder-led, and relentless in our pursuit of “medicines for life”. We continue to research and develop treatments for cardiovascular and pulmonary diseases, and other orphan diseases.
How you’ll contribute
The Product Complaint Intake Specialist will coordinate, enact, and manage processes governing robust product complaint data collection for UTC products for proper management of product safety benefit risk, including 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. Proactively ensure quality and compliance with the established PC process and share any failure or inconsistencies for resolution or closure with UT Global Product Safety (GPS) Management. This is a hybrid position with 3 days/week in our RTP, NC office and 2 days/week work from home.
+ Support the overall process and evaluation of regulatory changes and strategically ensure the effectiveness and efficiency of processes for the Product Complaint Intake function
+ Assist in providing quality and compliance oversight for the designated vendor and all associated workflows, including but not limited to the product complaint workflows/handling, product complaint investigations, maintaining unified product defect investigation operating procedures, maintaining and monitoring systems to ensure that all product complaint investigations received are appropriately investigated and concluded per the company's complaint handling procedure, potentially reportable MDRs, returned goods authorizations, field alert reports, etc.
+ Assist in providing training and/or education in conjunction with the Brand Safety Lead (BSL) and the product FMEAs for the UT product(s) with respect to potential product complaints or user issues that could be experienced; use medical expertise to create and provide training as well as using medical expertise to make independent medical assessments on qualification of a report meeting MDR reporting or FAR reporting criterion
+ Remain current on global regulations, guidelines and industry best practices for end-to-end case management (SAEs) and ensure compliance with global regulations and guidelines for development/non-development programs relating to product complaint handling, product complaint investigations and reporting MDRs
+ Coordinate the 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
+ Interface/act as point of contact with the Specialty Pharmacies or other 3rd parties suppling return goods authorization for product return for 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)
+ Support and perform as needed all steps specific to intake, data entry, follow-up and investigations for product complaints in accordance with UT policies & procedures
+ Assist with oversight of PC intake activities outsourced to vendors, including training, issue resolution, process updates/enhancements and compliance
+ Perform other duties as assigned
For this role you will need
Minimum 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
+ Experience with Microsoft Office applications (i.e. Word, Excel, PowerPoint, Outlook)
+ Experience with TrackWise, TrackWise Digital or similar product complaint management system
Preferred Qualifications
+ Registered Nurse (RN)
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 https://www.unither.com/careers/benefits-and-amenities
_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._
Source : United Therapeutics
