Job Title: Lead Pharmacovigilance QC Specialist
Job Location: Chapel Hill, NC, USA
Job Location Type: Remote
Job Contract Type: Full-time
Job Seniority Level: Mid-Senior level
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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 RequirementsThis job is curated by Lifelancer.
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