• Lead product safety surveillance and oversee evolving safety and benefit-risk profiles for assigned products. • Lead cross-functional safety management team (SMT) for assigned products, and responsible for the on-going assessment of benefit-risk profiles and related actions during the product life cycle. • Review safety data from various sources (e.g. pre-clinical, clinical trial data, post-marketing, literature) throughout the development process as well as post marketing for assigned products. • Responsible for conducting signal detection activities, monitoring, evaluation, interpretation and appropriate management and communication of safety information • Represent pharmacovigilance on cross-functional product/project teams including review of safety sections of protocols, investigator brochures, informed consent forms, and other documents with safety content. • Responsible for strategy and key content of Risk Management documents (DRMPs, RMPs, REMS) and regulatory responses. • Provide strategy and guidance to safety risk management scientists in writing of periodic reports for assigned products; provide medical interpretation, review and approval. • Responsible for up-to-date representation of safety information in Company Core Data Sheet and Investigator Brochure, and other labeling documents. • Perform the medical review of all adverse event reports for seriousness, expectedness and causality. • Coach, mentor and manage safety scientists supporting the surveillance activities for assigned products. • Represent Pharmacovigilance function in committees and activities both internally and externally when appropriate.