Location: Onsite/Hybrid
#LI-Hybrid #LI-Onsite

To work collaboratively with internal and external stakeholders to lead Risk Evaluation and Mitigation Strategies (REMS) in the Novartis portfolio.

Your Key Responsibilities:
• Serves as the Novartis safety REMS expert on project/product teams throughout the product life cycle and contributes to the development and implementation of innovative, evidence-based risk management solutions, including enhanced pharmacovigilance and risk minimization activities that will ensure optimized benefit with minimized risk
• Provides oversight of the tactical implementation and monitoring of REMS commitments including ensuring timely submission of reporting requirements to FDA
• Works closely with Regulatory Affairs, Medical Affairs, and Pharmacovigilance in the development and management of REMS
• Monitor and report progress of program launches and operations, identify risks, highlight issues, seek input/approval from management
• Ensures compliance with REMS regulatory requirements and coordinates REMS training programs across Novartis
• Coordinates the use of external consultants/vendors as appropriate based on business needs to operationalize large scale ETASU REMS programs
• Participate and/or lead the evaluation & selection of vendors according to Novartis procurement policies where applicable
• Develop and manage vendor contracts with the support of project teams
• Manage REMS budgets, review and approve vendor invoices, and review and approve program deliverables
• Establishes policies appropriate for the function
• Interprets and recommends modifications to company-wide policies and practices