Remote
RTP, NC
Remote- US
Full time
R05301
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:
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
Are you ready to play a critical role in strengthening United Therapeutics' global pharmacovigilance partnership framework by ensuring high-quality, compliant, and timely safety data exchange across global business partners, affiliates, alliances, and QPPVs. This role provides expert operational governance of partner-related case management, reconciliation, reporting quality, and compliance activities to support accurate processing and submission of post-marketing adverse events in alignment with UT procedures and applicable global requirements.
Serving as a key escalation point and strategic advisor, this role will evaluate complex ICSR, governance, regulatory, and inspection-readiness issues; recommend risk-based solutions; and lead cross-functional initiatives that enhance partnership oversight, improve process efficiency, and help protect
patient safety through complete, consistent, and reliable safety reporting.
Oversee day-to-day quality, compliance, case-management, data exchange, and reconciliation activities for UT global business partners to ensure discrepancies are resolved and post-marketing adverse events are processed and submitted in accordance with UT procedures and applicable requirements
Maintain unified safety data exchange procedures and monitoring controls that support complete, accurate, timely, and consistent partner reporting activities
Monitor global regulations, guidelines, and industry practices related to safety data collection, end-to-end case management, and data exchange, and provide expert guidance regarding operational implementation
Evaluate complex ICSR compliance, governance, quality, safety-reporting, inspection, and regulatory issues, and recommend risk-based solutions that consider patient safety, regulatory obligations, business objectives, and operational feasibility
Serve as the primary functional escalation point for partner-related compliance, governance, quality, reconciliation, and safety-reporting issues involving UT business partners, GPS affiliates, partner alliances, and QPPVs
Recommend improvements to partnership oversight programs, functional practices, governance processes, quality systems, and operating procedures based on identified risks, performance trends, and business needs
Initiate and lead projects and cross-functional initiatives that improve partner oversight, process efficiency, reporting quality, compliance, and inspection readiness
Contribute to departmental planning and implementation of goals for the GPS Partnership Program Oversight function within established functional objectives
Develop and deliver procedures, training, and supporting materials for adverse event, product complaint, and special reporting situation collection and reporting in accordance with applicable procedures and requirements
Act as a functional subject matter expert and point of contact during inspections and audits involving partner safety data exchange and GVP case-management processes
Conduct root-cause analyses and support the timely development, implementation, and closure of corrective and preventive actions arising from partner-related inspection findings, audit observations, deviations, or compliance issues
Review and approve partner-related deviations and corrective and preventive actions within assigned authority
Perform other duties as assigned
Education and Experience requirements for Senior Global Safety Partnership Oversight Manager level:
Bachelor's degree in chemistry, biology, or a related field
10+ years of experience in pharmacovigilance in end-to-end case processing of ICSRs with a bachelor's degree, or
8+ years of experience in pharmacovigilance in end-to-end case processing of ICSRs with a master's degree, or
5+ years of experience in pharmacovigilance in end-to-end case processing of ICSRs with a PharmD
4+ years of product development and/or postmarketing drug experience
4+ years of experience as QPPV, deputy QPPV, or supporting role
4+ years of experience in operations oversight (mgmt. of KPIs, compliance, metrics, etc.)
4+ years of experience in managing or implementing PVAs with international business partners
Education and Experience requirements for Associate Global Safety Partnership Oversight Director level:
Bachelor's degree in chemistry, biology, or a related field
12+ years of experience in pharmacovigilance in end-to-end case processing of ICSRs with a bachelor's degree, or
10+ years of experience in pharmacovigilance in end-to-end case processing of ICSRs with a master's degree, or
7+ years of experience in pharmacovigilance in end-to-end case processing of ICSRs with a PharmD or international equivalent
6+ years of experience as QPPV, deputy QPPV, or related supporting function
6+ years of experience in operations oversight (management of KPIs, compliance, metrics, etc.)
6+ years of experience in managing or implementing PVAs with international business partners
Minimum Requirements
Prior pharmacovigilance experience with demonstrated expertise in safety data exchange, adverse event reporting, compliance oversight, and partnership management activities supporting global pharmacovigilance operations
Advanced knowledge of global pharmacovigilance regulations, guidance, and industry best practices related to safety data exchange, adverse event reporting, reconciliation, and end-to-end case management for drugs, biologics, devices, and combination products
Advanced knowledge of drug development, post-marketing safety surveillance, and regulatory frameworks supporting product development, registration, safety monitoring, and reporting obligations
Working knowledge of pharmacovigilance agreements, quality agreements, inspection readiness practices, quality systems, and corrective and preventive action processes supporting global safety compliance activities
Demonstrated experience using safety databases and supporting technologies, preferably Argus or equivalent pharmacovigilance systems
Demonstrated project leadership skills with the ability to independently plan, organize, manage, and deliver large or complex projects, initiatives, and process improvements
Strong analytical thinking and problem-solving skills with the ability to
