Global Safety Lead

Serves as Global Safety Lead 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 and represents the cross-functional program team as a product safety profile and risk mitigation expert for internal and external stakeholders. Accountabilities include analyzing and interpreting safety data, conducting signal detection, developing strategy for responses to safety-related inquiries, and ensuring communication of all safety information. Provides medical safety expertise, reviews critical documents, and collaborates on clinical development programs. Manages benefit-risk profile, communicates safety issues, and interacts with Regulatory Authorities.