Associate Director, Safety Scientist, Global Patient Safety | T678

Location: Barcelona, Spain
Job reference: R-211271
Date posted: 10/21/2024
This is what you will do:The Associate Director, Safety Scientist plays a leadership role within Global Patient Safety (GPS) to actively evaluate and manage risk in collaboration with the GPS Medical Director(s) and cross-functional team members within the global regulatory framework.
You will be responsible for:
Managing safety scientist activities across multiple product portfolios and/or indicationsOrganizing, training and/or supporting junior safety scientists and fellowsSupporting activities related to new drug applications and other regulatory filingsRepresenting global patient safety at regulatory inspections e.g., MHRA, FDA, EMA, etc.Leading gap analysis to ensure alignment with changes in global regulationsStrategizing and drafting responses to regulatory inquiries on product safety issues inclusive of defining Med DRA search strategyRepresenting GPS in global program teams and associated cross-functional teams and/or projects as neededProactively providing guidance and educational training to GPS therapeutic teamsResponsible for Signal Review Meeting and Signal Management Team activities in collaboration with GPS Medical DirectorsPerforming Signal Surveillance activities for respective programs in collaboration with GPS Medical DirectorsProject managing and authoring safety documents including PSUR, PBER, PADER, RMP, REMS, CSRs, and ad hoc requests in collaboration with GPS Medical DirectorsAuthoring safety sections, in collaboration with team members, on regulatory responses, IBs/CCDS, protocols, ICFs, Data Monitoring Committee reports and requests, and other documents, and providing the necessary quality control to ensure alignment with core safety position
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