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Johnson & Johnson is seeking a Head of Product Safety for Solid Tumors in the United States (New Jersey) to oversee safety strategy and risk management for marketed and developmental oncology products. You will supervise safety teams, shape global safety processes, and maintain regulatory communications.
The role requires MD or equivalent with 10+ years in pharma oncology, and strong pharmacovigilance expertise within a matrix organization.
Responsibilities: direct medical safety strategies, lead Medical Safety Officers and Safety Analysis Scientists, ensure compliance with regulatory safety requirements, develop safety documentation, and manage safety communications with stakeholders including regulatory bodies, clinical teams, and senior management. Collaborate with global safety and R&D leaders to optimize safety processes, support regulatory inspections, and oversee safety-related policy development.
Qualifications: Physician (MD or equivalent) with 10+ years pharmaceutical industry experience, clinical expertise, and management experience supervising safety teams. Strong background in oncology, pharmacovigilance, and post-marketing safety assessment. High-value specifics: oncology (solid tumors), drug development phase, post-marketing safety, pharmacovigilance, regulatory compliance, and global safety strategy.
Skills: excellent communication, regulatory knowledge, leadership in a matrix environment, proficiency in safety data analysis, and experience with safety reporting and risk management frameworks.