Associate Director, Safety Science, Global Drug Safety & Pharmacovigilance

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The Associate DirectorSafety Science in Global Drug Safety & Pharmacovigilance (DSPV) will be  responsible for global safety assessment of investigational and marketed products throughout their lifecycle.  This includes all pre- and post-marketing safety, Pharmacovigilance (PV) and risk management activities.  This individual will work together with the Safety Science team and Global DSPV in managing the safety assessment of products, including review of individual and aggregate AEs and the scientific literature, preparing safety reports and communicating changes in the product risk profile to internal and external stakeholders.  The ability to work in a dynamic, rapidly changing environment to meet corporate and patient needs is essential.

Remote: Officially documented as working full-time from home, with travel to Ultragenyx's offices or other locations on occasion as needed.

• Provide DSPV expertise for Ultragenyx Commercial and Clinical Development programs including Clinical, Investigator Sponsored, Compassionate Use, and Disease Monitoring Programs and represent DSPV at study execution and strategic development forums; liaise with Clinical Sciences, Clinical Operations, Medical Affairs, Biostatistics, Regulatory Affairs, Contract Research Organizations (CROs), Data Monitoring Committees (DMCs) and other entities as needed to contribute to overall study execution while ensuring safety strategy and operational excellence. 
• Contribute to the preparation and review of safety-related section(s) for clinical, regulatory, and scientific documents including protocols, informed consent/assent forms, case report forms (CRFs), statistical plans, clinical study reports/synopses, integrated summaries of safety, New Drug or Biologic License Applications (NDA/BLA), Marketing Authorization Applications (MAA), Common Technical Document (CTD) submissions, Regulatory Agency responses, IRB/EC requests, manuscripts/journal articles and other documents as needed.
• Leads and/ or contributes to the creation and maintenance of Reference Safety Information (RSI) including Investigator Brochures (IB), Company Core Data Sheet (CCDS), Company Core Safety Information (CCSI), national labels and other associated product labeling.
• Perform review of medical/scientific literature to identify literature relevant for signal detection activities and aggregate reporting for assigned products.
• Leads and/or participates in signal detection activities to allow signal identification, evaluation, validation, for assigned products including individual and aggregate data analyses; interpretation of safety signals and trends; documentation and communication of safety assessments (written and verbal) of safety risks in collaboration with key internal/external stakeholders.
• Lead author and/or contributor to the preparation of pre- and post- marketing aggregate safety reports including Periodic Safety Update Reports (PSURs)/Periodic Benefit Risk Evaluation Reports (PBRERs), Periodic Adverse Drug Experience Reports (PADERs), Development Safety Update Reports (DSURs), IND Annual Reports, and 6-monthly Suspected Unexpected Serious Adverse Reactions (SUSARs) Line Listing Reports and ensure consistent communication of safety topics across various regulatory safety documents for assigned products.
• Leads and/or contributes to risk-benefit evaluations and preparation of Risk Management Plans (RMPs) for assigned products ensuring identification of risks, appropriate risk minimization and effectiveness measures in accord with regulatory requirements.

• Bachelor's level degree with advanced degree preferably in scientific field; Healthcare professional degree preferred (MD, MPH, PharmD, RPh, RN/BSN).
• A minimum of 8 years in a PV Safety Science role within the pharmaceutical/biotechnology industry; other relevant experience may be considered
• Excellent understanding of global PV regulatory environment with working knowledge of international regulations, initiatives, standards and Good Pharmacovigilance practices (GVP) including but not limited to Americas, European Union, Latin-America and Asia-Pacific territories including a thorough understanding of case processing and other pharmacovigilance processes
• Working knowledge of safety databases (ARISg, ARGUS, or other safety database applications) and electronic data capture systems
• Working experience with PV audit process with active participation in Regulatory Authority Inspections
• Ability to manage multiple tasks with deadlines in fast-paced working environment with demonstrated successful management of complex projects within the scope of this position
• Requires a high level of initiative and independence
• Must have excellent written and oral communication skills, resourcefulness and personal organization skills together with demonstrated cross-functional teamwork
• Willingness to travel. There may be circumstances where business needs require remote team members to travel / work in the office including national / international travel #LI-CS1 #LI-Remote