Global Safety Scientist
Ultragenyx is a biotechnology company committed to bringing to market novel products for the treatment of rare and ultra-rare diseases with an initial focus on serious debilitating metabolic genetic 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 diseases for which the unmet medical need is high, the biology for treatment is clear, and for which there are no approved therapies.
Come join our team during this exciting time of growth and opportunities![MY1]
This position is 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 Medical Director of Drug Safety and Pharmacovigilance (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.
Responsibilities, including but not limited to:
- Provide DSPV expertise for Ultragenyx Clinical Development program 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, Biometrics, 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.
- Leads and/or participates in the Safety Management Team (SMT) and Product Safety Committee (PSC) meetings for assigned products
- 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
- Provides guidance with adverse event (MedDRA) and drug (WHODrug) coding; performs clinical trial SAE reconciliation
- Participate in individual case safety report (ICSR) case management to ensure timely and accurate reporting of ICSRs
- 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 Drug Safety & Pharmacovigilance 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 (SDEA)
- Contribute to vendor governance activities and key performance indicators to ensure DSPV excellence.
- 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 staff; develop and provide training within specific areas of knowledge
- Bachelor’s level degree with advanced degree preferably in scientific field; Healthcare professional degree preferred (MD, MPH, PharmD, RPh, RN/BSN).
- 6-8 years global clinical and post-marketing DSPV experience - Global Safety Scientist 9-10 years
- 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
- 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.
- Some national/international travel may be required
Ultragenyx Pharmaceutical is an equal opportunity employer & prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital and veteran status.
Note to External Recruiters: All candidate activity and open positions are managed strictly through our Human Resources Department. Our Human Resources Department kindly requests that recruiters not contact employees/hiring managers directly in an attempt to solicit business and present candidates. Please note that failure to comply with this request will be a factor in determining a professional relationship with our organization. Submission of unsolicited resumes prior to an agreement set in place between the Human Resources Department and the recruiting agency will not create any implied obligation. Inquiries on developing a recruiting relationship with us, may be directed to: email@example.com.