Director, Safety Science, Global Drug Safety and Pharmacovigilance at Ultragenyx in

Why Join Us? Be a hero for our rare disease patients 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. Our commitment and care for patients extends to our people, so culture is an essential cornerstone for Ultragenyx. We remain continuously focused on creating a supportive and inclusive environment of profound learning and growth – so employees can thrive in all areas of their lives, in and outside of work. Ultimately, we want to be an organization where we would be proud for our family, friends and children to work. If you want to have a meaningful impact, do the best work of your career, and grow a lot, both professionally and personally, come join our team.

Position Summary:

ultrafocused – Work together to fearlessly uncover new possibilities

The Director, Safety Science in Global Drug Safety & Pharmacovigilance (DSPV) will be a key contributor to the global benefit risk strategy and overall safety profile for a portfolio of Ultragenyx marketed and clinical development products throughout the product(s) lifecycle. This includes supporting or leading all major pre- and post- marketing safety deliverables including signal, benefit-risk evaluation and risk management activities. This individual must effectively interface cross-functionally at all levels in the organization as well as with external Regulatory Authorities. The Director, Safety Science will work together with DSPV staff and other stakeholders in managing the safety assessment of products, including review of individual and aggregate safety data and the scientific literature, preparing safety reports and communicating changes in the product risk profile to internal and external stakeholders. The experienced individual must have executive presence, superb written and verbal communication skills, and the ability to work in a dynamic, changing environment to meet corporate and patient needs is essential.

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:

Manage all pre- and post-marketing safety surveillance activities for assigned Ultragenyx products (investigational and marketed) throughout lifecycle in compliance with ICH guidelines, FDA / EMA / applicable global health authority regulations related to Good Pharmacovigilance Practices (GVP), and Ultragenyx policies and procedures
Lead and/or provide input to global safety strategy ensuring proactive and continuous review and assessment of pre-clinical, clinical, and post-marketing safety data to ensure positive benefit-risk profile for assigned programs in collaboration with key stakeholders
Provide DSPV leadership and input for Clinical Development programs including Investigator Sponsored, Compassionate Use, Named Patient Use, and Disease Monitoring Programs; liaise with Clinical Development, Clinical Operations, Medical Affairs, Biostatistics, Regulatory Affairs, Contract Research Organizations (CROs), Data Monitoring and Steering Committees and other entities to contribute to overall study execution while ensuring safety monitoring, quality, compliance and operational excellence
Participate on Program Core Team (PCT), Development Sub-Team (DST) and other decision-making forums for assigned programs
Lead/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
Provide DSPV leadership to support Ultragenyx Commercial organization global launch activities for assigned programs
Establish effective collaboration with DSPV, Clinical Development, Clinical Operations, Regulatory Affairs, Biostatistics, and Medical Affairs and other functional areas to align on harmonized approach in identifying, evaluating, validating, and communicating safety issues
Provide medical review of individual case safety reports (clinical and spontaneous) and all safety analyses to ensure accurate coding (MedDRA and WHODrug), seriousness, expectedness and company causality assessment, appropriate medical interpretation, consistency in case assessment and accurate reporting to Health Authorities, Ethics Committees, and business partners.
Lead review of medical/scientific literature to identify literature relevant for signal detection activities and aggregate reporting for assigned products

Requirements:

Bachelor's level degree with advanced degree preferably in scientific field; Healthcare professional degree preferred (MD, MPH, PharmD, RPh, RN/BSN).
A minimum of 8 years in an advanced PV role within the pharmaceutical/biotechnology industry; other relevant experience may be considered
Able to interface well with all levels of personnel, including peers and other Development and Commercial department heads such as: Biostatistics, Clinical, Commercial, Medical Affairs, Program Management, Regulatory Affairs, Quality
Capacity to produce high quality results across multiple programs and non-program initiatives and prioritize demands while working under short deadlines associated with a fast-paced dynamic scientific environment
Demonstrated knowledge of pharmaceutical research and development, global safety and PV regulatory environment with working knowledge of international regulations including but not limited to FDA, EMA, ICH guidelines and regulations pertaining to clinical development and post- marketing safety and their interpretation
Willingness to travel. There may be circumstances where business needs require remote team members to travel / work in the office including national / international travel #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.

Pay Range$200,600—$247,800 USD Full Time employees across the globe enjoy a range of benefits, including, but not limited to: · 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 * Benefits vary by region and country

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 talentacquisition@ultragenyx.com.

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