Your responsibilities will be but not limited to: Evaluate and establishes the safety profile of this product in collaboration with the different company experts and/or partner vendors Provide medical input with respect to safety aspects of : the documents intended to be submitted in an accelerated approval procedure, preparation of investigator brochures, Development safety update reports Be responsible for safety surveillance activities for this product including medical review of individual safety cases directly in the safety database and signal detection activities (ongoing review of safety data) Ensure the oversight of medical activities outsourced to our PV vendor Develop and lead, in collaboration with the relevant functions within clinical medicine, biometry and clinical pharmacology the implementation of a signal detection tool. Be a member of study teams and work in a collaborative and proactive way in a matrix environment. Participate in IDMC meeting or other safety related interactions with outside collaborators, and in internal safety task forces.