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

United Therapeutics Corporation•RTP, NC, NC

4d•$145,500 - $205,000•Hybrid

About The Position

United Therapeutics (UT) is seeking a Senior Global Safety Partnership Oversight Manager or Associate Global Safety Partnership Oversight Director to play a critical role in strengthening the company's global pharmacovigilance partnership framework. This role ensures high-quality, compliant, and timely safety data exchange across global business partners, affiliates, alliances, and QPPVs. The position 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. The role serves as a key escalation point and strategic advisor, evaluating complex ICSR, governance, regulatory, and inspection-readiness issues, recommending risk-based solutions, and leading cross-functional initiatives to enhance partnership oversight, improve process efficiency, and protect patient safety through complete, consistent, and reliable safety reporting.

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

Nice To Haves

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

Responsibilities

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