Director, Global Drug Safety & Pharmacovigilance Operations
Novato, CA or Brisbane, CA
Ultragenyx – Drug Safety/ Pharmacovigilance
Why Join Us?
Ultragenyx is a clinical stage biotechnology company committed to bringing to market novel products for the treatment of rare and ultra-rare diseases with an initial focus on serious debilitating metabolic genetic diseases. Founded in 2010, the company has rapidly built a diverse portfolio of both large and small molecule candidates with the potential to address diseases for which the unmet medical need is high, the biology for treatment is clear, and for which there are no approved therapies.
Come join our team during this exciting time of growth and opportunities!
We are headquartered in Novato, CA, 25 miles north of San Francisco, and we also have an office in Brisbane, CA, 10 miles south of San Francisco.
The Director Global Drug Safety & Pharmacovigilance (DSPV) Operations will be responsible for the oversight and management of case processing activities for all clinical stage and commercial Ultragenyx (UGNX) products on a world-wide basis. The position requires an experienced leader who can be hands-on and execute the tactics as well as provide direction and strategy on process improvements and overall team effectiveness. The individual is required to effectively prepare groups for anticipated product approvals and manage increasing volume of clinical trial and post-marketing safety reports. The individual is responsible for ensuring key performance indicators are met/exceeded for compliance and quality of all deliverables. The individual must maintain excellent relationships with all stakeholders, vendors, licensed partners and other third parties internal and external to UGNX.
Responsibilities, including but not limited to:
- Lead the establishment and oversee the PV operational and case management activities for PV Operations including the collection, processing, and reporting/submission of safety information for all UGNX products (investigational and commercial) in accordance with all applicable regulatory requirements, Good Pharmacovigilance practices (GVP) or guidelines and UGNX internal operating procedures (e.g., SOPs)
- Participate in the development, implementation and maintenance of UGNX (including vendor) PV system including policies, SOPs, and forms to ensure compliance with all applicable regulatory requirements or guidelines, GVP and industry best practices
- Assume active role in development and subsequent maintenance of UGNX Pharmacovigilance System Master File (PSMF)
- · Establish, implement, and maintain Global AE training policy for UGNX and ensure UGNX compliance with policy internally/externally
- Ensure compliance with all regulatory reporting requirements and timelines for reporting safety data from clinical studies and post-marketed use
- Participate in the PV vendor evaluation and selection process as well as vendor set-up and execution of PV vendor agreements (e.g., MSA/SOW)
- Supervise the day-today activities of, monitor and evaluate the performance and quality of PV vendor responsible for case management and other PV activities
- Participate in the selection, implementation and maintenance of the global safety database to ensure compliance with global AE reporting requirements
- Ensure implementation of processes and systems internally (where necessary) and externally (PV vendor) to ensure AE information is received timely, reviewed for completeness and consistency, and case follow-up activities are completed to facilitate signal detection and aggregate safety reporting activities
- Ensure literature search strategies are performed on weekly basis and all relevant articles are assessed for adverse reactions and benefit-risk information
- Supervise and contribute to the development and maintenance of Safety Data Exchange Agreements (SDEAs), PV agreements (PVAs), Statements of Work, manage partner relationships, and ensure compliance with PVAs
- Ensure reconciliation of AE reports received from other company operating units, affiliates, contractual vendors, partners, CROs, as applicable
- Liaise with the EU Qualified Person for Pharmacovigilance (EU-QPPV) and Deputy-QPPV on regular basis and ensure they are kept well informed of any activities relating to PV, appropriately consulted and recommendations are acted upon
- Ensure PV Operations support for UGNX development programs and SAE reconciliation of clinical and safety databases for ongoing clinical studies
- Work with internal/external partners to develop procedures for AE handling and training (e.g., Investigator Meeting or Site Initiation Visit trainings) ; Ensure SAE reconciliation of clinical and safety databases for ongoing clinical studies
- Contribute to the development and maintenance of safety sections for clinical and regulatory documents (e.g. Protocols, Informed Consent, and other reports as necessary)
- Liaise with colleagues in but not limited to BioStatistics/Data Management, Clinical Development, Clinical Operations, Clinical Sciences, Commercial, Legal, Medical Affairs, Product Quality, Regulatory Affairs to ensure processes are in place for activities performed by those functions that impact PV including a full range of PV and cross-functional activities
- Implement & document Corrective Action and Preventative Actions (CAPAs) as needed to ensure compliance with UGNX policies/procedures and regulations
- Ensure PV inspection readiness internally and externally, prepare for and have a central role in PV Regulatory Authority inspections and in relevant internal/external audits; ensure subsequent Corrective Action and Preventative Actions (CAPAs) are documented and implemented as planned
- Contribute to safety requests from Regulatory Authorities
- Serve as PV Operations Lead for organized data collection activities such as Disease Monitoring Programs, Patient Support or Expanded Access Programs and Investigator Initiated Trials/Studies
- Ensure global PV regulations are monitored for updates and that changes are implemented as appropriate
- Ensure document management system for management, retrieval, and archiving
- Provide training, coaching and mentorship to PV & other UGNX sta
- Bachelor’s level degree with advanced degree preferably in scientific field; Healthcare professional degree preferred (PharmD, RPh, RN, MPH).
- 11-15 years global DSPV experience; other relevant experience may be considered.
- Management experience in pharmaceutical safety including a thorough understanding of case processing and other pharmacovigilance processes
- Excellent understanding of global PV regulatory environment with working knowledge of international regulations, initiatives, standards and Good Pharmacovigilance (GVP) practices including but not limited to Americas, European Union, Latin-America and Asia-Pacific territories including a thorough understanding of case processing and other pharmacovigilance processes
- Demonstrated success in initiating and managing partnerships with external vendors.
- Demonstrated successful management and leadership of complex projects within the scope of this position
- Working knowledge of safety databases (ARISg, ARGUS, or other safety database applications) and electronic data capture systems
- Prior safety database migration & PV integration experience required
- Working experience with PV audit process with active participation in Regulatory Authority Inspections
- Working knowledge of MedDRA and WHO Drug coding dictionaries
- Excellent knowledge of drug development process.
- Requires a high level of initiative and independence
- Some national/international travel required
Ultragenyx Pharmaceutical is an equal opportunity employer & prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital and veteran status.