Director, Safety Science, Global DSPV

Position Summary:

ultrafocused – Work together to fearlessly uncover new possibilities

Responsible for leading global safety surveillance and strategy for assigned products across their lifecycle, ensuring compliance with international pharmacovigilance regulations. Collaborates cross-functionally and with regulatory authorities to assess benefit-risk, lead signal detection, manage aggregate reports, and support regulatory submissions. Performs Medical review, coordinate safety governance with documentation, and participate in inspection readiness activities. 

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 
• Involved in inspection readiness activities, internal audits and external inspections  
• Contribute to the generation and maintenance of Pharmacovigilance Agreements (PVAs)  

Requirements:

• Healthcare professional degree (MD/ DO/ PharmD).  
• 8+ years industry experience, with knowledge of pharmaceutical clinical research and development, preferably in rare disease,  global safety and PV regulatory environment with working knowledge of international regulations, programs, standards of Good Pharmacovigilance Practices (GVP) including, Americas, European, Latin-America and Asia-Pacific territories including FDA, EMA, ICH guidelines on clinical development and post-marketing safety and their interpretation. 
• BLA/MAA experience preferred with success working with Regulatory authorities (FDA, EMA etc.) at type C, B, pre-BLA/MAA meetings, Advisory Committee meetings, or other scientific advice forums.  
• Experience in the principles and techniques of data analysis, proficient in data analysis software and data presentation; interpretation and clinical relevance.  
• Experience developing risk management strategies and plans.  
• Experience in signal detection, writing aggregate reports (PBRER/ Annual safety report) 
• Working knowledge of industry standard safety databases (ARGUS and ARISg), Regulatory databases, and other electronic data capture systems. 
• 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