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.

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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:

• 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)

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

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