Senior Account Manager
Trustpair
Executive Director, Safety Science – Global
Ultragenyx
full-time
Posted on:
Origin: • 🇺🇸 United States
Visit company websiteSalary
💰 $324,000 - $400,300 per year
Job Level
Lead
About the role
- Provide DSPV leadership in support of development, registration, and life-cycle management for assigned Ultragenyx portfolio of products
- Guide, coach, and manage Safety Science professionals and their managers to ensure professional development and advancement
- Lead and contribute to safety aspects 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
- Manage pre- and post-marketing safety surveillance activities in compliance with ICH guidelines, Good Pharmacovigilance Practices (GVP), and applicable global health authority regulations, guidance and best practices
- Build partnerships with key senior stakeholders from other functions to ensure strategic and operational business goals are met
- Liaise and negotiate with global regulatory authorities on drug safety issues and to expedite approvals
- Maintain awareness of the global regulatory environment, interpret PV regulations, and assess impact of changes on business and PV systems
- Proactively manage critical and urgent safety issues and lead DSPV contributions 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
- Management experience with advanced benefit-risk/safety data analyses experience
- Good written and verbal communication skills
- Hands-on pharmacovigilance (PV) experience with a proven track record of major accomplishments
- Rare disease experience in all phases of biologic, small molecule, mRNA and gene therapy drug development preferred, including IND/CTA, NDA/BLA/MAA experience and interacting with regulatory authorities or advisory committees
- 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, Good Pharmacovigilance Practices (GVP) and best practices
- Working knowledge of industry standard safety databases (ARGUS), regulatory databases, and other electronic data capture systems
- Strong medical science analytical reasoning skills; proficient in data analysis software and data presentation; interpretation and clinical relevance
- Excellent interpersonal communication and influencing skills; experience influencing executives and senior scientific management
- MedDRA trained and working knowledge of MedDRA and WHO Drug dictionaries
- Real-world experience supporting PV audits and health authority inspections
- Domestic/international travel may be required
