Executive Director, Safety Science, Global DSPV

OverviewExecutive Director, Safety Science, Global DSPVResponsibilitiesProvides DSPV leadership in support of the development, registration, and life-cycle management for assigned Ultragenyx portfolio of productsGuides, coaches, managers assigned Safety Science professionals to ensure their professional development and advancementLead/contribute to the safety aspect of interactions with Regulatory authorities worldwide (FDA, EMA etc.) at type C, B, pre-BLA/MAA/NDS meetings, Scientific Advice, Advisory Committee meetings, or other scientific advice forums for portfolio productsProvide DSPV leadership to support Ultragenyx Commercial organization global launch activities for portfolio productsManages pre- and post-marketing safety surveillance activities in compliance with ICH guidelines, Good Pharmacovigilance Practices (GVP), and all applicable global health authority regulations, guidance and best practicesBuilds partnerships with key senior stakeholders from other functions to ensure strategic and operational business goals are met through the sharing of knowledge, expertise and the provision of appropriate resourcesLiaises and negotiates with global regulatory authorities as needed for all aspects pertaining to drug safety, including resolution of key regulatory-safety issues and to expedite approvals of productsMaintains awareness of global regulatory environment, facilitates interpretation of PV regulations, and assesses impact of changes on business and PV systemProactively manages critical and urgent safety issues, taking leadership for the DSPV contribution for portfolio productsDevelop and implement department policies, processes and SOPsSupport inspection readiness activities, internal audits, and external inspections for Safety ScienceContribute to the generation and maintenance of Pharmacovigilance Agreements (PVAs)RequirementsMD requiredMinimum of 12 years in a senior/advanced PV Science role within the pharmaceutical/biotechnology industry, with at least 5 years in supervisory capacityRare disease experience in all phases of biologic, small molecule, mRNA and gene therapy drug development preferred including IND/CTA, NDA/BLA/MAA experience with success interacting with Regulatory authorities, Advisory Committees, or other scientific advice forumsStrong people management skills, willingness to develop team and help others succeedExtensive working knowledge of global PV/safety regulatory environment including ICH, international regulations, guidelines, standards of Good Pharmacovigilance Practices (GVP) including best practices and implementationWorking knowledge of industry standard safety databases (ARGUS), Regulatory databases, and other electronic data capture systemsStrong medical science analytical reasoning skills with experience in the principles and techniques of data analysis, proficient in data analysis software and data presentation; interpretation and clinical relevanceExcellent interpersonal communication, and influencing skills (up and down); success influencing executives and senior level scientific management as well as external representation of companyMedDRA trained and working knowledge of MedDRA and WHO Drug dictionariesReal-world supporting PV audits and health authority inspectionsDomestic / international travel may be requiredCompensationThe base pay range listed in the job posting is $324,000.00/yr - $400,300.00/yr. The typical annual salary range for this full-time position is listed below and may be adjusted based on geographic location. This position is eligible for annual bonus and equity incentives.BenefitsGenerous vacation time and public holidays observed by the companyVolunteer daysLong term incentive and Employee stock purchase plans or equivalent offeringsEmployee wellbeing benefitsFitness reimbursementTuitions sponsoringProfessional development plansBenefits vary by region and countryCompany informationUltragenyx 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 . See our CCPA Employee and Applicant Privacy Notice. See our Privacy Policy. 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.Seniority levelDirectorEmployment typeFull-timeJob functionManagement and Manufacturing #J-18808-Ljbffr

Created: 2025-10-06