United Therapeutics
Senior Global Patient Safety Quality, Training & Compliance Manager
United Therapeutics, Oklahoma City, Oklahoma, United States, 73116
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) .
Overview
The job details are as follows: Who we are We are the first publicly-traded biotech or pharmaceutical company to take the form of a public benefit corporation. Our public benefit purpose is to provide a brighter future for patients through the development of novel pharmaceutical therapies; and technologies that expand the availability of transplantable organs. United Therapeutics (Nasdaq: UTHR) seeks to travel down the corridors of indifference to develop treatments for rare, deadly diseases. We were founded in 1996 by a family seeking a cure for their daughters pulmonary arterial hypertension (PAH). Today, we have six FDA-approved therapies that treat PAH, pulmonary hypertension associated with interstitial lung disease (PH-ILD) and neuroblastoma, a rare pediatric cancer. Our near-term pipeline seeks to develop additional therapies for PAH and pulmonary fibrosis (PF). The cure for end-stage life-threatening diseases like PAH, PH-ILD, PF, and many others is an organ transplant, but only a small percentage of donated organs are available to address the vast need. For this reason, we are working to create manufactured organs to address the shortage of kidneys, hearts, lungs, and livers available for transplant. We believe an unlimited supply of tolerable, transplantable organs will eliminate the transplant waiting list and cure end-stage organ diseases for which transplant is not currently an option. Who you are You have a background in nursing or pharmacy and youre passionate about pharmacovigilance! You are a team player who loves quality, compliance, finding solutions and ensuring training standards are implemented and successful. This role in Global Patient Safety (GPS) will focus on enhancing and maintaining quality, training, and compliance (QTC) of GPS operations and practices. They will serve as a Subject Matter Expert for pharmacovigilance (PV), quality practices, education/training, and audits/inspections to support both commercial and development products. The QTC role will lead and advise on QTC PV matters relating to trials for advanced regenerative therapies, development and commercial products, driving GPS Operational Excellence. They will lead and advise during PV audit and inspections, enhancing compliance, with UT key stakeholders and partners. They will also support educational initiatives and training curricula for all GPS staff, vendors, contractors & other UT employees supporting PV activities. Responsibilities
Note: The original content describes role focus and leadership in QTC PV matters, audits/inspections, and training. The refined description preserves these responsibilities as described in the source. Minimum Requirements
Bachelors degree in life sciences or related field, and 10+ years of experience in pharmacovigilance in the pharmaceutical industry; or Masters degree in a medical/scientific or related field, and 8+ years of experience in pharmacovigilance in the pharmaceutical industry; or 5+ years of working knowledge of Global and Local PV regulation, and Quality Management principles 5+ years of experience in managing Quality Management Systems/Records in PV in the pharmaceutical industry 5+ years of management of pre-, peri-, and post-pharmacovigilance audits and inspections 5+ years of experience in oversight or establishing training in Pharmacovigilance related areas including PV Operations, Safety and Medical Science, Affiliate, Alliance and Contracts Management, and PV Systems Preferred Qualifications
PhD/PharmD/MD RN Registered Nurse State Licensure and/or Compact State Licensure, or Pharm-D Registered Pharmacist, or RPH Registered Pharmacist Job Location & Travel
This position can be located either in the Durham, NC office on a hybrid schedule (in office requirements could increase based on business needs), or can be located remotely within the continental US. If located remotely, this position would require travel up to 20%. Benefits
Eligible employees may participate in the Companys 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 At United Therapeutics, our mission and vision are one. We use our enthusiasm, creativity, and persistence to innovate for the unmet medical needs of our patients and to benefit our other stakeholders. We are bold and unconventional. We have fun, we do good. United Therapeutics Corporation is an Equal Opportunity Employer, including veterans and 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. #J-18808-Ljbffr
The job details are as follows: Who we are We are the first publicly-traded biotech or pharmaceutical company to take the form of a public benefit corporation. Our public benefit purpose is to provide a brighter future for patients through the development of novel pharmaceutical therapies; and technologies that expand the availability of transplantable organs. United Therapeutics (Nasdaq: UTHR) seeks to travel down the corridors of indifference to develop treatments for rare, deadly diseases. We were founded in 1996 by a family seeking a cure for their daughters pulmonary arterial hypertension (PAH). Today, we have six FDA-approved therapies that treat PAH, pulmonary hypertension associated with interstitial lung disease (PH-ILD) and neuroblastoma, a rare pediatric cancer. Our near-term pipeline seeks to develop additional therapies for PAH and pulmonary fibrosis (PF). The cure for end-stage life-threatening diseases like PAH, PH-ILD, PF, and many others is an organ transplant, but only a small percentage of donated organs are available to address the vast need. For this reason, we are working to create manufactured organs to address the shortage of kidneys, hearts, lungs, and livers available for transplant. We believe an unlimited supply of tolerable, transplantable organs will eliminate the transplant waiting list and cure end-stage organ diseases for which transplant is not currently an option. Who you are You have a background in nursing or pharmacy and youre passionate about pharmacovigilance! You are a team player who loves quality, compliance, finding solutions and ensuring training standards are implemented and successful. This role in Global Patient Safety (GPS) will focus on enhancing and maintaining quality, training, and compliance (QTC) of GPS operations and practices. They will serve as a Subject Matter Expert for pharmacovigilance (PV), quality practices, education/training, and audits/inspections to support both commercial and development products. The QTC role will lead and advise on QTC PV matters relating to trials for advanced regenerative therapies, development and commercial products, driving GPS Operational Excellence. They will lead and advise during PV audit and inspections, enhancing compliance, with UT key stakeholders and partners. They will also support educational initiatives and training curricula for all GPS staff, vendors, contractors & other UT employees supporting PV activities. Responsibilities
Note: The original content describes role focus and leadership in QTC PV matters, audits/inspections, and training. The refined description preserves these responsibilities as described in the source. Minimum Requirements
Bachelors degree in life sciences or related field, and 10+ years of experience in pharmacovigilance in the pharmaceutical industry; or Masters degree in a medical/scientific or related field, and 8+ years of experience in pharmacovigilance in the pharmaceutical industry; or 5+ years of working knowledge of Global and Local PV regulation, and Quality Management principles 5+ years of experience in managing Quality Management Systems/Records in PV in the pharmaceutical industry 5+ years of management of pre-, peri-, and post-pharmacovigilance audits and inspections 5+ years of experience in oversight or establishing training in Pharmacovigilance related areas including PV Operations, Safety and Medical Science, Affiliate, Alliance and Contracts Management, and PV Systems Preferred Qualifications
PhD/PharmD/MD RN Registered Nurse State Licensure and/or Compact State Licensure, or Pharm-D Registered Pharmacist, or RPH Registered Pharmacist Job Location & Travel
This position can be located either in the Durham, NC office on a hybrid schedule (in office requirements could increase based on business needs), or can be located remotely within the continental US. If located remotely, this position would require travel up to 20%. Benefits
Eligible employees may participate in the Companys 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 At United Therapeutics, our mission and vision are one. We use our enthusiasm, creativity, and persistence to innovate for the unmet medical needs of our patients and to benefit our other stakeholders. We are bold and unconventional. We have fun, we do good. United Therapeutics Corporation is an Equal Opportunity Employer, including veterans and 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. #J-18808-Ljbffr