Senior Director - Product Safety, Solid Tumors

• The Product Safety Head is responsible for safety oversight and strategic direction for multiple products within the Oncology solid tumors therapeutic area.
• Oversees a team of Medical Safety Officers (MSOs) leading product safety strategy and risk management activities in Global Safety Strategy & Risk Management (GSSRM).
• Charged with overseeing end-to-end medical safety strategy of both marketed and developmental phase activities of all the products within the assigned portfolio.
• Determines the need for safety risk mitigation measures.
• Maximize efficiency and effectiveness of safety-related activities by aligning around common processes, systems, and practices.
• Implements new approaches to support the scientific evaluation of the safety risk profile product.
• Ensures E2E support for complex development plans, regulatory submissions, and post marketing risk minimization requirements across multiple products.
• Ensures proactive and timely assessments of safety data, understanding the emerging and known safety profiles of products within the assigned product.
• Prepares aggregate safety reports and responses to Health Authorities (HA) and communicates potential and known risks to Senior Management, HAs, Prescribers and/or Patients.
• Ensures consistency of safety strategy execution and communications across multiple products within the assigned product.
• Maintains compliance with legal and regulatory requirements.

Requirements

• Clinical Operations
• Compliance Management
• Compliance Risk
• Developing Others
• Inclusive Leadership
• Industry Analysis
• Leadership
• Medicines and Device Development and Regulation
• Operations Management
• Quality Control (QC)
• Research Ethics
• Risk Management
• Risk Management Framework
• Safety Investigations
• Safety-Oriented
• Serious Adverse Event Reporting
• Standard Operating Procedure (SOP)
• Tactical Planning

Core Competencies

Demonstrates expertise in product safety oversight and strategic direction within the Oncology therapeutic area, ensuring compliance with regulatory requirements and effective risk management. Capable of leading teams in safety strategy execution and communication across multiple products.

Highest-signal resume keywords

• Clinical Operations
• Compliance Management
• Risk Management
• Safety Investigations
• Leadership

ATS Optimization Keywords

Hard Skills

• Safety Risk Mitigation
• Aggregate Safety Reporting
• Regulatory Submissions
• Quality Control (QC)
• Tactical Planning

Soft Skills

• Developing Others
• Inclusive Leadership

Industry Keywords

• Oncology
• Medicines and Device Development and Regulation
• Research Ethics
• Safety-Oriented
• Standard Operating Procedure (SOP)