Executive Director, Safety Science, Global DSPV

Ultragenyx Pharmaceutical

34d•Remote

About The Position

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.

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

Nice To Haves

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

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)