Sr. Manager, Global Patient Safety And Epidemiology
Current• Manage the GPSE Safety Science and Benefit Risk Management (SSBRM) team and processes for periodic safety update reports (PSURs), risk management plans (RMPs) and signal detection. • Train and mentor SSBRM team to facilitate engagement and adherence to company standard operating procedures (SOPs), policies and guidelines.• Participate in regulatory authority inspections and internal/external audits • Collaborate with multiple stakeholders and ensure compliance and high-quality standards to manage multiple, competing projects within given timelines. • Support business objectives by providing timely, balanced and comprehensive information on marketed and investigational products to promote safe, rational and effective use of products.• Escalate safety related issues and signals arising from review of pre and post marketed safety data.• Keep current with Pharmacovigilance regulations for modifications to internal procedures or changes to the agreements with vendors or partners as applicable.• Budget forecasting
