• Represent Medical Safety & Pharmacovigilance in Clinical Teams for assigned investigational products providing medical guidance in planning and gaining alignment for all safety matters and issues • Lead Safety Management Team(s) navigating complex safety issues for assigned Investigational product(s) and responsible for all associated risk management activities, including regular review of safety data for identification and evaluation of new safety signals • Provide safety review and safety content for critical development program documents including protocols, ICFs, IBs, IMPDs, CSRs, INDs, CTAs, and NDA/BLA/MAAs/IDMC Charters • Provide/oversee medical review of adverse event reports to ensure the accuracy, integrity and completeness of information entered in the safety database • Provide input in responding to and resolving safety questions from regulatory authorities • Provide input/oversee production of regulatory periodic safety submissions such as development safety update report (DSUR) and other aggregate safety reports for regulatory agencies worldwide