Executive Director, Global Pharmacovigilance Operations, Quality & Compliance

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🔥 0 minutes ago

🇺🇸 United States – Remote

💵 $301.1k - $371.9k / year

⏰ Full Time

🔴 Lead

🚔 Compliance

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Ultragenyx

WebsiteLinkedInAll Job Openings

501 - 1000 employees

Founded 2010

🏥 Healthcare

💼 Consulting

📦 Logistics

Healthcare • Consulting • Logistics

Ultragenyx is a biopharmaceutical company dedicated to transforming the lives of individuals with rare and ultrarare genetic diseases. The company focuses on developing and delivering treatments for conditions where no current therapies exist, utilizing a variety of drug modalities tailored to each disease. Ultragenyx boasts a robust and diverse clinical pipeline, with therapies in development for genetic diseases such as Wilson Disease, osteogenesis imperfecta, and Angelman Syndrome. With a passionate team and a commitment to patient advocacy, Ultragenyx aims to lead the way in pioneering therapies that significantly impact rare disease communities.

📋 Description

• Build, lead, coach, and mentor the Global Pharmacovigilance Operations, Quality & Compliance function and contribute to the Global DSPV talent strategy • Establish functional objectives, operating model priorities, and long-range goals aligned with Corporate and Global DSPV objectives • Ensure the global PV system is scalable, compliant, inspection-ready, and positioned to support portfolio growth, product approvals, commercialization, launches, and regional expansion • Lead global PV operations, including intake, triage, case processing, quality control, regulatory reporting/submission, reconciliation, and oversight of safety information • Ensure PV operational activities comply with global regulatory requirements, Good Pharmacovigilance Practices, and internal policies and procedures • Oversee PV operational performance, vendor execution, trend monitoring, and continuous improvement • Provide operational support for programs and PV-related TMF activities • Maintain PV policies, SOPs, procedures, forms, and process governance • Own oversight and management of the Pharmacovigilance System Master File • Establish and maintain the global adverse-event reporting training program and oversee training compliance • Lead DSPV deviation and CAPA strategy, including documentation, monitoring, trending, effectiveness checks, KPI development, quality/compliance metrics, and QSMR reporting • Oversee GVP due diligence, audits, inspections, responses, and commitment tracking • Lead PV vendor oversight and governance, including performance, quality, escalation, and compliance monitoring • Lead Safety Agreements/PVAs, Statements of Work, partner relationships, and contractual compliance • Support partner/vendor PV due diligence, audits, inspection readiness, and external governance forums • Perform other duties as assigned

🎯 Requirements

• Bachelor's level degree with advanced degree preferably in a scientific field; healthcare professional degree preferred (PharmD, RPh, RN/BSN, MPH) • Minimum 15 years of global full life-cycle DSPV experience, including clinical and post-marketing pharmacovigilance responsibilities • Direct experience in PV Operations, vendor/alliance management, and GVP-related Quality Management/Compliance within the pharmaceutical/biotechnology industry; rare disease experience preferred • Demonstrated experience leading global teams, including direct people leadership, matrix leadership, performance management, and talent development • Proven ability to influence senior stakeholders and collaborate cross-functionally with Clinical Development, Clinical Operations, Regulatory Affairs, Quality Assurance, Medical Affairs, Commercial, Legal/Contracts, vendors, partners, and senior management • Direct experience preparing for, leading, supporting, and responding to global regulatory authority PV/GVP inspections, including FDA and EMA inspections where applicable • Strong knowledge of global safety and PV regulatory requirements, GVP, FDA, EMA, ICH guidance, and applicable international regulations across clinical development and post-marketing safety • Experience leading/scaling a global PV operations, quality, and compliance function in a dynamic and growing organization • Demonstrated ability to lead through outsourced and vendor-heavy operating models • Experience supporting commercialization, product launches, portfolio growth, and regional expansion • Experience with PV system governance, process ownership, inspection-ready quality systems, and continuous improvement • Working knowledge of industry-standard safety databases, Trial Master File systems (e.g., Veeva Vault eTMF), and other electronic data capture systems • MedDRA trained with working knowledge of MedDRA and WHO Drug dictionaries • Willingness to travel, including national and international travel, as business needs require

🏖️ Benefits

• Generous vacation time and public holidays observed by the company • Volunteer days • Long term incentive and Employee stock purchase plans or equivalent offerings • Employee wellbeing benefits • Fitness reimbursement • Tuition sponsoring • Professional development plans