Global Safety Lead

Serves as Global Safety Lead (GSL) and the Company-wide patient safety expert for assigned pharmaceutical / biological / drug-device combined products, accountable for the safety strategy and major safety deliverables for each assigned product. Leads GPSE Safety Team (GST) and Safety Management Team (SMT) for assigned compounds and products. Represents the cross-functional program team as a product safety profile and risk mitigation expert for internal and external stakeholders. Manages cross-functional assessment of benefit-risk profile and communication of safety information. Analyze and interpret safety data from various sources. Conduct signal detection, monitoring, evaluation, interpretation, and management. Develop strategy for and lead preparation of responses to safety-related inquiries. Ensure communication of all safety information to senior management. Provide medical safety expertise for critical documents. Provide patient safety input to the clinical development program. Manage benefit-risk profile, including authoring and updating of the benefit-risk documents. Collaborate and communicate safety issues with other functional areas. Support GPSE in the maintenance of a highly effective global safety organization. Train and mentor Pharmacovigilance Physicians and Specialists.