United Therapeutics
Lead Pharmacovigilance QC Specialist
United Therapeutics, Myrtle Point, Oregon, United States, 97458
California, US residents.
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 daughter’s 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 been responsible and are a SME on evaluating and ensuring appropriate quality standards and adherence to case processing procedures. You are passionate about PV and enjoy partnering with vendors and partners to ensure the highest level of quality and compliance with respect to ISCR processing and reporting. The Lead Pharmacovigilance QC Specialist provides strategic oversight of end-to-end case safety quality, ensuring compliance, and quality in adverse effects, including individual case safety report (ICSR) adverse events, product complaints (PC), and special reporting situations (SRS) for UTC’s developmental and marketed products. As the lead, this role drives process improvements, and strengthens overall ICSR quality including retrospective review and ensuring proactive corrective/preventive actions are implemented to support safety surveillance and benefit-risk management. Minimum Requirements
Education and Experience Requirements:
Bachelor’s Degree in a related field such as chemistry or biology, or BSN, and 8+ years of experience in pharmacovigilance in either case processing or quality assurance of ICSRs (clinical trial cases & post-marketing reports), OR Master’s Degree in a related field such as chemistry or biology, and 6+ years of experience in pharmacovigilance in either case processing or quality assurance of ICSRs (clinical trial cases & post-marketing reports)
3+ years of experience in vendor management and oversight Previous experience using Argus (preferred) or other safety databases Preferred Qualifications
Master’s degree in a related field such as chemistry or biology 2+ years of experience in clinical trial or product development Knowledge of data entry processing, from start to finish (QC, medical review, regulatory submissions) Prior clinical or post marketing experience Job Location & Travel
United Therapeutics has the flexibility to hire this role remotely with a 20% travel expectation, OR based in our Durham, NC office with a hybrid schedule of three to four days onsite each week and with a 10% travel expectation. Travel may include both domestic and international trips. Benefits
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 United Therapeutics Corporation is an Equal Opportunity Employer, including veterans and individuals with disabilities.
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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 daughter’s 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 been responsible and are a SME on evaluating and ensuring appropriate quality standards and adherence to case processing procedures. You are passionate about PV and enjoy partnering with vendors and partners to ensure the highest level of quality and compliance with respect to ISCR processing and reporting. The Lead Pharmacovigilance QC Specialist provides strategic oversight of end-to-end case safety quality, ensuring compliance, and quality in adverse effects, including individual case safety report (ICSR) adverse events, product complaints (PC), and special reporting situations (SRS) for UTC’s developmental and marketed products. As the lead, this role drives process improvements, and strengthens overall ICSR quality including retrospective review and ensuring proactive corrective/preventive actions are implemented to support safety surveillance and benefit-risk management. Minimum Requirements
Education and Experience Requirements:
Bachelor’s Degree in a related field such as chemistry or biology, or BSN, and 8+ years of experience in pharmacovigilance in either case processing or quality assurance of ICSRs (clinical trial cases & post-marketing reports), OR Master’s Degree in a related field such as chemistry or biology, and 6+ years of experience in pharmacovigilance in either case processing or quality assurance of ICSRs (clinical trial cases & post-marketing reports)
3+ years of experience in vendor management and oversight Previous experience using Argus (preferred) or other safety databases Preferred Qualifications
Master’s degree in a related field such as chemistry or biology 2+ years of experience in clinical trial or product development Knowledge of data entry processing, from start to finish (QC, medical review, regulatory submissions) Prior clinical or post marketing experience Job Location & Travel
United Therapeutics has the flexibility to hire this role remotely with a 20% travel expectation, OR based in our Durham, NC office with a hybrid schedule of three to four days onsite each week and with a 10% travel expectation. Travel may include both domestic and international trips. Benefits
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 United Therapeutics Corporation is an Equal Opportunity Employer, including veterans and individuals with disabilities.
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