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:

Responsible for leading global safety surveillance, benefit risk strategy and life-cycle management for a portfolio of Ultragenyx products, ensuring compliance with international pharmacovigilance regulations. The experienced individual must have management experience with advanced benefit-risk/safety data analyses experience, good written and verbal communication skills, as well as hands-on PV experience with a proven track record of major accomplishments.
ultrainnovative – Tackle rare and dynamic challenges

REQUIREMENTS:

• MD required
• Minimum of 12 years in a senior/advanced PV Science role within the pharmaceutical/biotechnology industry, with at least 5 years in supervisory capacity
• Rare 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 forums
• Strong people management skills, willingness to develop team and help others succeed
• Extensive working knowledge of global PV/safety regulatory environment including ICH, international regulations, guidelines, standards of Good Pharmacovigilance Practices (GVP) including best practices and implementation
• Working knowledge of industry standard safety databases (ARGUS), Regulatory databases, and other electronic data capture systems
• Strong 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 relevance
• Excellent interpersonal communication, and influencing skills (up and down); success influencing executives and senior level scientific management as well as external representation of company
• MedDRA trained and working knowledge of MedDRA and WHO Drug dictionaries
• Real-world supporting PV audits and health authority inspections
• Domestic / international travel may be required
  

  LI-CS1 #LI-Remote

• Provides DSPV leadership in support of the development, registration, and life-cycle management for assigned Ultragenyx portfolio of products
• Guides, coaches, managers assigned Safety Science professionals to ensure their professional development and advancement
• 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 for portfolio products
• Provide DSPV leadership to support Ultragenyx Commercial organization global launch activities for portfolio products
• Manages pre- and post-marketing safety surveillance activities in compliance with ICH guidelines, Good Pharmacovigilance Practices (GVP), & all applicable global health authority regulations, guidance and best practices
• Builds 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 resources
• Liaises 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 products
• Maintains awareness of global regulatory environment, facilitates interpretation of PV regulations, and assesses impact of changes on business and PV system
• Proactively manages critical and urgent safety issues, taking leadership for the DSPV contribution for portfolio products
• Develop and implement department policies, processes and SOPs
• Support inspection readiness activities, internal audits, and external inspections for Safety Science
• Contribute to the generation and maintenance of Pharmacovigilance Agreements (PVAs)