Senior Global Safety Partnership Oversight Manager / Associate Global Safety Partnership Oversight Director

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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

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 evaluate complex compliance, quality, reconciliation, and safety-reporting issues, identify root causes, and recommend practical risk-based solutions
- Strong communication, collaboration, and stakeholder-management skills with the ability to work effectively across functions and influence internal and external stakeholders without direct authority
- Ability to understand the objectives, activities, dependencies, and required contributions of internal partner functions and external business partners supporting pharmacovigilance activities
- Ability to exercise independent judgment when evaluating compliance risks, safety-reporting challenges, inspection observations, reconciliation discrepancies, and operational issues
- Ability to adapt effectively to evolving regulatory requirements, changing business priorities, and ambiguous operating environments
- Ability to challenge existing practices, identify opportunities for improvement, recommend alternative approaches, and support implementation of approved process and operational changes
- Ability to develop and deliver procedures, training materials, and operational guidance that promote compliance, consistency, and quality across partnership oversight activities
- Ability to analyze compliance metrics, operational performance indicators, and quality trends to identify risks and drive continuous improvement initiatives
- Ability to serve as a functional subject matter expert and escalation resource for partnership oversight, safety data exchange, compliance, quality, and reconciliation activities

Preferred Qualifications

- Master’s degree in chemistry, biology, or a related field
- Doctor of Pharmacy (PharmD)

Job Location

United Therapeutics has the ability to hire this role remotely within the continental United States, with a preference to candidates residing in, or willing to relocate to RTP, NC. For local candidates, this position will be located at our Durham, NC office with a hybrid schedule of 3 days in office and the option to work 2 days each week from home. In office requirements could change based on business needs.

The salary range for the Senior Global Safety Partnership Oversight Manager position is $145,500 - $190,000 and the salary range for the Associate Global Safety Partnership Oversight Director position is $167,500 - $205,000 and reflects our good-faith estimate of the compensation for this role at the time of posting. An employee’s position within the salary range will be based on factors such as education, qualifications, experience, skills, geographic location, and business needs, as well as other factors permitted by law at the time of posting. This range may be modified in the future based on company and market factors.

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.

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.