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Global Safety Physician

Ultragenyx is a biopharmaceutical company committed to developing treatments for rare and ultra-rare diseases. Founded in 2010, the company has rapidly built a diverse portfolio of small molecule, monoclonal antibody, mRNA and gene therapy candidates with the potential to address debilitating genetic diseases for which the unmet medical need is high, the biology for treatment is clear, and for which there are no approved therapies.   Developing new treatments for rare genetic diseases is challenging work. It takes courage, talent, and dedication to look past the easy answers and uncover new solutions that can make a meaningful impact. At Ultragenyx we push each other to perform at our very best, because we never lose sight of our mission - to make a difference in our patients' lives.   Come join our team during this exciting time of growth and opportunities! Position Summary ultracurious - Apply your biggest ideas in courageous ways The Global Safety Physician, Drug Safety & Pharmacovigilance (DSPV) serves as the safety expert accountable for the global safety strategy and overall safety profile for Ultragenyx products (investigational and marketed) throughout their lifecycle. This includes leading all major pre- and post-marketing safety deliverables including signal, benefit-risk evaluation and risk management activities. This individual must effectively interface cross-functionally at all levels in the organization as well as with external Regulatory Authorities. This individual will work together with DSPV staff 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, changing environment to meet corporate and patient needs is essential. Responsibilities, including but not limited to:  Provide DSPV leadership for Ultragenyx Clinical Development including Clinical, Investigator Sponsored, Compassionate Use, and Disease Monitoring Programs; liaise with Clinical Sciences, Clinical Operations, Medical Affairs, Biometrics, Regulatory Affairs, Contract Research Organizations (CROs), Data Monitoring Committees (DMCs) and other entities to contribute to overall study execution while ensuring safety strategy and operational excellence  Provide DSPV leadership to Ultragenyx Commercial organization to support global launch activities for assigned products  Lead 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, briefing books, manuscripts/journal articles and other documents as needed, ensuring safety profile reflected for assigned products  Direct the creation and maintenance of Company Core Safety Information (CCSI) and ensure implementation of CCSI in all Reference Safety Information (RSI) including Investigator Brochures (IBs), Company Core Data Sheet (CCDS), 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  Lead signal detection activities to ensure 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 and/or participate on Safety Management Team (SMT), Product Safety Committee (PSC), and other executive forums for assigned products  Contribute 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 profile/topics across various regulatory safety documents for assigned products  Lead risk-benefit evaluations and contribute to preparation of Risk Management Plans (RMPs) for assigned products ensuring identification of risks, appropriate risk minimization and effectiveness measures in accord with regulatory requirements  Provide guidance with adverse event (MedDRA) and drug (WHODrug) coding for clinical and post-marketing safety data  Provide medical review of individual case safety reports (clinical and spontaneous) and all safety analyses to ensure accurate coding, seriousness, expectedness and company causality assessment, appropriate medical interpretation, consistency in case assessment and accurate reporting to Health Authorities, Ethics Committees, and business partners.  Develop or contribute to development of Ultragenyx or department processes including policies, Standard Operating Procedures and other relevant safety documentation (eg. Safety Management Plans, data entry guidelines, etc.)  Demonstrate knowledge and ensure compliance with current and applicable global PV regulations and guidelines (e.g., CIOMS, EMA, FDA, ICH, etc.), Ultragenyx SOPs and quality standards  Actively involved in inspection readiness activities, internal audits and external inspections  Represent DSPV in cross-functional forums and committees to achieve the Company's goals  Participate in the PV vendor selection activities and contribute to the generation of Pharmacovigilance Agreements (PVAs) or Safety Data Exchange Agreements (SDEAs)  Contribute to vendor governance activities and key performance indicators to ensure DSPV excellence  Provide safety expertise to due diligence activities as needed  Maintain knowledge of Ultragenyx diseases for investigational and/or marketed products assigned  Keeps abreast of new PV/safety regulations and guidance from the regulatory authorities  Mentor junior DSPV staff; develop and provide training within specific areas of knowledge Technical Requirements & Skills:  MD required; medical licensure in at least one state preferred; clinical research and/or fellowship training in genetics, pediatrics, endocrinology, metabolism, pharmacology or other relevant specialty is a plus.  Minimum 2-4 years Drug Safety/Pharmacovigilance experience plus 2 years clinical development experience; 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  Exposure to working relationship with the FDA and other regulatory authorities is preferred  Strong knowledge of individual adverse event case report processing, triage and medical review  Working knowledge of safety databases (ARISg, ARGUS, or other safety database applications) and electronic data capture systems  MedDRA trained and working knowledge of MedDRA and WHODrug coding dictionaries  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  Excellent knowledge of drug development process  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  Computer literacy with proficiency in external Regulatory Databases, Microsoft Excel, PowerPoint and Word  Some national/international travel may be required
Salary Range: NA
Minimum Qualification
Less than 5 years

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