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

United Therapeutics Corporation

. Oversee day-to-day quality, compliance, case-management, data-exchange, and reconciliation activities for global business partners .

Posted 9/24/2026full-timeDurham • North Carolina • United StatesSenior💰 $145,500 - $205,000 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates extensive expertise in pharmacovigilance, including end-to-end ICSR case processing, safety data exchange, and compliance oversight. Proven ability to lead cross-functional initiatives, manage complex projects, and develop training materials while ensuring adherence to global regulations and industry best practices.

Highest-signal resume keywords

Pharmacovigilance ExperienceEnd-to-End ICSR Case ProcessingGlobal Pharmacovigilance RegulationsSafety Data ExchangeProject Management

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

PharmacovigilanceICSR Case ProcessingCompliance OversightAdverse Event ReportingQuality SystemsCAPA ProcessesData AnalysisRegulatory FrameworksProcess ImprovementInspection Readiness

Soft Skills

Analytical ThinkingProblem-SolvingCommunicationCollaborationStakeholder Management

Tools & Technologies

ArgusSafety DatabasesPharmacovigilance Systems

Industry Keywords

Pharmacovigilance AgreementsQuality AgreementsPost-Marketing Safety SurveillanceOperational GuidancePartnership Management

About the role

Key responsibilities & impact

Oversee day-to-day quality, compliance, case-management, data-exchange, and reconciliation activities for global business partners
Maintain unified safety data-exchange procedures and monitoring controls
Monitor global regulations, guidelines, and industry practices and provide operational guidance
Evaluate complex ICSR compliance, governance, quality, inspection, and regulatory issues
Serve as the primary escalation point for partner-related compliance, governance, quality, reconciliation, and safety-reporting issues
Recommend improvements to partnership oversight programs, governance processes, quality systems, and operating procedures
Lead projects and cross-functional initiatives improving partner oversight, process efficiency, reporting quality, compliance, and inspection readiness
Contribute to planning and implementation of GPS Partnership Program Oversight goals
Develop and deliver procedures, training, and supporting materials for adverse-event, product-complaint, and special-reporting collection and reporting
Act as subject matter expert during inspections and audits involving partner safety data exchange and GVP case-management processes
Conduct root-cause analyses and support corrective and preventive actions
Review and approve partner-related deviations and corrective and preventive actions within assigned authority
Perform other duties as assigned

Requirements

What you’ll need

Bachelor’s degree in chemistry, biology, or a related field
10+ years of pharmacovigilance experience in end-to-end ICSR case processing with a bachelor’s degree, or 8+ years with a master’s degree, or 5+ years with a PharmD (Senior Manager level)
12+ years of pharmacovigilance experience in end-to-end ICSR case processing with a bachelor’s degree, or 10+ years with a master’s degree, or 7+ years with a PharmD or international equivalent (Associate Director level)
4+ years of product development and/or postmarketing drug experience (Senior Manager level)
4+ years of experience as QPPV, deputy QPPV, or supporting role (Senior Manager level)
4+ years of experience in operations oversight (Senior Manager level)
4+ years of experience managing or implementing PVAs with international business partners (Senior Manager level)
6+ years of experience as QPPV, deputy QPPV, or related supporting function (Associate Director level)
6+ years of experience in operations oversight (Associate Director level)
6+ years of experience managing or implementing PVAs with international business partners (Associate Director level)
Prior pharmacovigilance experience with expertise in safety data exchange, adverse event reporting, compliance oversight, and partnership management
Advanced knowledge of global pharmacovigilance regulations, guidance, and industry best practices
Advanced knowledge of drug development, post-marketing safety surveillance, and regulatory frameworks
Working knowledge of pharmacovigilance agreements, quality agreements, inspection readiness, quality systems, and CAPA processes
Experience using safety databases and supporting technologies, preferably Argus or equivalent pharmacovigilance systems
Ability to independently plan, organize, manage, and deliver complex projects and process improvements
Strong analytical thinking and problem-solving skills
Strong communication, collaboration, and stakeholder-management skills
Ability to understand internal partner functions and external business partners supporting pharmacovigilance activities
Ability to exercise independent judgment when evaluating compliance risks and operational issues
Ability to adapt to evolving regulatory requirements and changing business priorities
Ability to identify process improvements and support implementation of operational changes
Ability to develop and deliver procedures, training materials, and operational guidance
Ability to analyze compliance metrics, operational performance indicators, and quality trends
Ability to serve as a functional subject matter expert and escalation resource

Benefits

Comp & perks

Medical, dental, vision, and prescription coverage
Employee wellness resources
401(k) savings plan
Employee Stock Purchase Plan (ESPP)
Paid time off
Paid parental leave benefits
Disability benefits