(Jo816) Director, Safety Science

.(JO816) Director, Safety Science Barcelona, Catalonia (JO816) Director, Safety ScienceBarcelona Barcelona, Catalonia, ES This is what you will do:The Director, Safety Scientist plays a leadership role within Global Patient Safety organizing and mentoring safety scientists to actively evaluate, manage and strategize risk in collaboration with the GDS Medical Directors and cross-functional team members within the global regulatory frameworkYou will be responsible for:Leading risk management evaluation and resolution for assigned products and projects. Accountability for the following:Proven skill set for strategic leadership in a cross functional matrixOrganize,train and/or support junior safety scientists and fellows across multiple product portfolios and/or indicationsCo-lead activities related to new drug applications and other regulatory filingsRepresent global patient safety at regulatory inspections i. e. MHRA, FDA, EMA, etc. Lead analysis to identify and address changes in global regulations including updates to SOP and process documentationLeading activities to identify and address process gapsResponsible for vendor management and training including budgetsResponsible for overall project distribution across therapeutic areaAs needed represent GPS in global program teams and associated cross functional teams and/or projectsProactively provide guidance and educational training to GPS therapeutic teamsParticipate in ongoing safety data review and analysis for products in designated therapeutic areas. Responsible for Signal Review Meeting and Signal Management Team activities in collaboration with GPS Medical DirectorsResponsible for project managing and authoring of safety documents including PSUR, PBER, PADER, RMP, REMS, CSRs, and ad hoc requests in collaboration safety physicians. Responsible for authoring safety section in collaboration with team members on regulatory responses, IBs/CCDS, protocol, ICF review,Data Monitoring Committees reports and requests, and other documents, and provide the necessary quality control to ensure alignment with core safety position