Ultragenyx
Executive Director, Global Pharmacovigilance Operations, Quality & Compliance
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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.
Ultragenyx Cambridge, Massachusetts, USA Office
840 Memorial Dr, Cambridge, MA, United States, 02139
Ultragenyx Somerville, Massachusetts, USA Office
100 Chestnut St, Somerville, United States, 02143
Ultragenyx Waltham, Massachusetts, USA Office
303 Wyman St, Waltham, MA, United States, 02451
Ultragenyx Woburn, Massachusetts, USA Office
19 Presidential Way, Woburn, MA, United States, 01801
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