Product Safety Head – Solid Tumors

• The Product Safety Head is responsible for safety oversight and strategic direction for multiple products within the Oncology solid tumors therapeutic area.
• Oversee a team of Medical Safety Officers (MSOs) leading product safety strategy and risk management activities in Global Safety Strategy & Risk Management (GSSRM).
• Help ensure consistency of safety strategy execution and communications across multiple products within the assigned product.
• Maintain compliance with legal and regulatory requirements.

• Safety oversight and strategic direction for multiple products within the Oncology solid tumors therapeutic area.
• Overseeing end-to-end medical safety strategy of both marketed and developmental phase activities of all the products within the assigned portfolio.
• Determine the need for safety risk mitigation measures.
• Maximize efficiency and effectiveness of safety-related activities by aligning around common processes, systems, and practices.
• Implement new approaches to support the scientific evaluation of the safety risk profile product.
• Ensure E2E support for complex development plans, regulatory submissions, and post marketing risk minimization requirements across multiple products.
• Ensure proactive and timely assessments of safety data, understanding the emerging and known safety profiles of products within the assigned product.
• Preparation of aggregate safety reports and responses to Health Authorities (HA).

Demonstrates expertise in safety oversight and strategic direction within the Oncology solid tumors therapeutic area, ensuring compliance with regulatory requirements and effective risk management across multiple products.

• Safety Oversight
• Oncology Solid Tumors
• Risk Management
• Regulatory Compliance
• Medical Safety Strategy

• Safety Risk Mitigation
• Aggregate Safety Reports
• E2E Support for Development Plans
• Safety Data Assessment
• Regulatory Submissions

• Leadership
• Communication
• Team Management

• Global Safety Strategy
• Health Authorities
• Post Marketing Risk Minimization
• Safety Profile Evaluation
• Common Processes and Systems