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The Executive Director, Global Pharmacovigilance Operations, Quality & Compliance is accountable for the strategic leadership, operational effectiveness, and inspection-ready performance of Ultragenyx's global Pharmacovigilance (PV) Operations, Quality & Compliance function. This role oversees global case processing for investigational and marketed products, PV vendor oversight and governance, Alliance Management, Pharmacovigilance System Master File (PSMF) oversight, PV quality/compliance systems, training, deviation and Corrective and Preventive Action (CAPA) management, audit and inspection preparedness, and operational Trial Master File (TMF) support. The role ensures the global PV system is scalable, compliant, and prepared to support portfolio growth, product approvals, commercialization, regional expansion, and successful regulatory inspections.
Work Model:Remote: Officially documented as working full-time from home, with travel to Ultragenyx's offices or other locations on occasion as needed.
Responsibilities:Functional Leadership & Strategy
- Build, lead, coach, and mentor the Global Pharmacovigilance Operations, Quality & Compliance function and contribute to the Global DSPV talent strategy aligned with company long-range growth plans.
- 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.
PV Operations
- Lead global PV operations, including intake, triage, case processing, quality control, regulatory reporting/submission, reconciliation, and oversight of safety information from all applicable products and sources.
- Ensure PV operational activities comply with applicable global regulatory requirements, Good Pharmacovigilance Practices (GVP), and Ultragenyx internal policies and procedures.
- Oversee PV operational performance, vendor execution, trend monitoring, and continuous improvement to maintain inspection-ready execution.
- Provide operational support for all programs and oversight for PV-related TMF activities, as applicable.
PV Quality & Compliance
- Ensure maintenance of the Ultragenyx PV system, including PV policies, SOPs, procedures, forms, and process governance in alignment with global regulatory requirements, GVP, and industry best practices.
- Own oversight and management of the Ultragenyx PSMF, ensuring on-demand readiness and compliance with applicable regulatory requirements.
- Establish and maintain the global AE reporting training program and oversee training compliance with applicable Ultragenyx policies and procedures.
- Lead DSPV deviation and CAPA strategy, including initiation, documentation, monitoring, trending, effectiveness checks, KPI development, quality/compliance metrics, and Quality System Management Review (QSMR) reporting.
- Oversee GVP due diligence, audits, inspections, responses, and commitment tracking to ensure all PV audit and inspection commitments are fulfilled on time.
Alliance Management & Vendor Governance
- Lead PV vendor oversight and governance, including performance, quality, escalation, and compliance monitoring for vendors responsible for PV activities.
- Lead Safety Agreements/PVAs, Statements of Work, partner relationships, and contractual compliance with PVAs and related safety commitments.
- Support partner/vendor PV due diligence, audits, inspection readiness, and external governance forums involving vendors, licensed partners, and other third parties.
- Other duties as assigned.
- 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.
#LI-CS1 #LI-Remote
The typical annual salary range for this full-time position is listed below. This range reflects the characteristics of the job, such as required skills and qualifications and is based on the office location noted in this job posting. The range may also be adjusted based on applicant's geographic location.
This position is eligible for annual bonus and equity incentives. Actual individual pay is determined by demonstrated experience and internal equity alignment.
Ultragenyx Pharmaceutical is an equal opportunity employer and prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital and veteran status, and any other status or classification protected by applicable federal, state, and/or local laws. Reasonable accommodation will be provided for all protected statuses or classifications protected by applicable law, including individuals with disabilities, disabled veterans, for pregnancy, childbirth, and related medical conditions, and based on sincerely held religious beliefs. Applicants can request an accommodation prior to accepting a job offer. If you require reasonable accommodation in completing this application, or in any part of the recruitment process, you may contact Talent Acquisition by emailing us at [email protected].
It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.
Skills Required
- Bachelor's degree; advanced degree preferably in a scientific field, with healthcare professional degree preferred
- Minimum 15 years of global full life-cycle drug safety and pharmacovigilance experience, including clinical and post-marketing responsibilities
- Direct experience in pharmacovigilance operations, vendor or alliance management, and GVP quality management or compliance within the pharmaceutical or biotechnology industry
- Experience leading global teams through direct and matrix leadership, performance management, and talent development
- Ability to influence senior stakeholders and collaborate cross-functionally with clinical, regulatory, quality, medical, commercial, legal, vendor, and partner teams
- Experience preparing for, leading, supporting, and responding to global regulatory authority pharmacovigilance and GVP inspections, including FDA and EMA inspections where applicable
- Strong knowledge of global safety and pharmacovigilance regulatory requirements, GVP, FDA, EMA, ICH guidance, and applicable international regulations
- Experience leading or scaling a global pharmacovigilance operations, quality, and compliance function in a dynamic organization
- Ability to lead through outsourced and vendor-heavy operating models
- Experience supporting commercialization, product launches, portfolio growth, and regional expansion
- Experience with pharmacovigilance system governance, process ownership, inspection-ready quality systems, and continuous improvement
- Working knowledge of industry-standard safety databases, Trial Master File systems such as Veeva Vault eTMF, and electronic data capture systems
- MedDRA training and working knowledge of MedDRA and WHO Drug dictionaries
- Willingness to travel nationally and internationally as business needs require
Ultragenyx Compensation & Benefits Highlights
The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about Ultragenyx and has not been reviewed or approved by Ultragenyx.
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Healthcare Strength — Benefits begin on the first day with multiple medical plan options alongside dental and vision coverage. Employer-funded HSA contributions and employer-paid mental health support via Spring Health add notable depth to healthcare support.
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Leave & Time Off Breadth — Paid time off is broadened by two fully paid company shutdown weeks in August and December in addition to holidays and baseline vacation. Paid sick time, paid volunteer time, and a substantial paid leave program further expand time-off support.
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Retirement Support — Retirement support includes a 401(k) program with a match on employee contributions and immediate vesting. An employee stock purchase plan discount also strengthens the overall financial rewards package.
Ultragenyx Insights
What We Do
At Ultragenyx, we fundamentally believe that taking real impactful action to care for the needs of patients and our people is always the right thing to do. To achieve this goal, our vision is to lead the future of rare disease medicine. For us, this means going where other biopharma companies won’t go – challenging the status quo and creating a new model that advances our field so more patients and caregivers can benefit from life-changing treatments. We do this by following the science, applying a novel rapid development approach, making innovative medicines at fair and reasonable prices, and creating a collaborative ecosystem to reach patients in ways that are most meaningful for them.
