Product Safety Head (Sr Director) - Solid Tumors

About the role

The Product Safety Head is responsible for safety oversight and strategic direction for multiple products within the Oncology solid tumors therapeutic area. The Product Safety Head oversees a team of Medical Safety Officers (MSOs) leading product safety strategy and risk management activities in Global Safety Strategy & Risk Management (GSSRM).

Responsibilities

• Oversee end-to-end medical safety strategy of both marketed and developmental phase activities of all the products within the assigned portfolio and determine the need for safety risk mitigation measures.
• Maximize efficiency and effectiveness of safety-related activities by aligning around common processes, systems, and practices, and implementing 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) and, when appropriate, communication of potential and known risks to Senior Management, HAs, Prescribers and/or Patients.
• Ensure consistency of safety strategy execution and communications across multiple products within the assigned product.
• Maintain compliance with legal and regulatory requirements.

Requirements

Required Skills:

• 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

Preferred Skills

• 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

Pay

The anticipated base pay range for this position is: $196,000.00 - $342,700.00

Schedule

Full-time

Benefits

• Consolidated Retirement Plan (pension)
• Savings Plan (401(k))
• Long-term incentive program
• Vacation –120 hours per calendar year
• Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado –48 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar year
• Holiday pay, including Floating Holidays –13 days per calendar year
• Work, Personal and Family Time - up to 40 hours per calendar year
• Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child
• Bereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar year
• Caregiver Leave – 80 hours in a 52-week rolling period10 days
• Volunteer Leave – 32 hours per calendar year
• Military Spouse Time-Off – 80 hours per calendar year

Additional Description

For Pay Transparency The anticipated pay range for this role is $199,000 - $343,275.