Jay Ehrlich Email & Phone Number

ESSENTIAL RESPONSIBILITIES for Global Patient Safety:• Accountable for developing strategies and directing all activities in the Global Patient Safety organization.• Accountable for working with the EU Qualified Person(s) for Pharmacovigilance and Global Pharmacovigilance Head to ensure that compliant pharmacovigilance and medical device vigilance practices are established and maintained in accordance with national, regional and global regulatory expectations.• Partners with business Med Affairs and R&D VPs to ensure appropriate collaboration with the MA and R&D teams to drive patient safety throughout the product life cycle. • Represent GPS in Field Action Review Boards and be the decision maker for patient safety-related field actions.• Represent the Global Patient Safety function both internally and externally; specifically, establish and maintain relationships with the leaders of the Baxter global businesses and global functions.• Support the creation, implementation and maintenance of standardized departmental procedures for all functions within Global Patient Safety (e.g., PV Benefit-Risk, PV Safety Operations, and Compliance).• Ensure appropriate communication with Baxter senior management regarding all relevant patient safety and PV system compliance issues.• Work with Global Regulatory Affairs to communicate relevant drug and device safety issues with potential patient impact to Ministries of Health globally.• Partner with Quality to ensure Medical Device Vigilance processes are reviewed and remain appropriate. ESSENTIAL RESPONSIBILITIES for Clinical Research:• Accountable for clinical research team and enhancing Baxter’s ability and methodologies for clinical evidence generation through excellence in clinical trial design as well as partnership with HEOR/RWE and WWM Strategy and Delivery. • Drives changes in internal and external landscape regarding clinical trial research excellence.• Responsible for the direction and design of clinical studies globally.• Responsible for ensuring collaboration with GBU MA leaders and WWM Strategy and Delivery for forecasting clinical research needs and negotiating prioritization as needed across projects.• Partners with GPS and Quality to ensure appropriate medical monitoring, management of patient safety and quality issues in clinical research. • Lead, manage, and develop Clinical Research staff.• Collaborate with team members from Clinical Operations, RA, Quality, and GBU to drive clinical research programs. Builds effective bridges between regions, GBU, and central MA/CD functions.

Listed skills include Pharmacovigilance, Drug Safety, Clinical Development, Pharmaceutical Industry, and 15 others.