Senior Manager, Product Safety Team Program Manager

Senior Manager overseeing product safety team program management at a pharmaceutical company. Responsible for strategic leadership, safety governance support, and cross-functional coordination throughout the drug product lifecycle to ensure regulatory compliance and optimal benefit-risk profiles.

Responsibilities

• Manage communications and meeting logistics for product safety teams and governance bodies
• Organize cross-functional meetings and prepare inspection-ready safety documentation meeting global requirements
• Support audit and inspection readiness through corrective action implementation and documentation
• Contribute to risk assessments and benefit-risk discussions using drug safety knowledge
• Develop safety communications and presentations to inform stakeholder decisions and discussions

Requirements

• 5+ years project management experience with cross-functional teams in global organizations
• 5+ years healthcare industry experience with working knowledge of drug development processes
• Background in clinical operations, clinical studies, drug development, risk management, or drug safety operations
• Bachelor's degree in healthcare discipline (Life Science, Pharmacy, Nursing) or equivalent certification
• Strong verbal and written communication skills for diverse audiences and senior leadership
• Experience collaborating with senior leaders and functional managers in matrix environments
• Solid understanding of drug safety regulations and clinical development requirements