Safety Operations Physician

Role: Medical Review Physician responsible for pharmacovigilance in clinical oncology development, particularly for RAS-targeted therapies. Objectives include ensuring safety data integrity, assessing Serious Adverse Events (SAEs), and supporting benefit–risk evaluations throughout drug lifecycle. Responsibilities encompass medical evaluation of ICSRs, causality and seriousness assessment, case narrative review, and oversight of safety case management. The role involves providing medical leadership, mentoring review teams, contributing to safety process improvements, and ensuring compliance with global regulations (ICH, GVP, FDA, EMA). Cross-functional collaboration with Clinical Development, Regulatory, Biostatistics, and Safety teams is essential, with active participation in safety signal detection, risk management, and quality audits. High-value specifics include experience with biologics and small molecules in oncology, especially RAS inhibitors in clinical phases. Qualifications require an MD/DO or equivalent, 5–8+ years in pharmacovigilance or drug safety, proficiency in safety database systems (e.g., Argus), coding dictionaries (MedDRA), and regulatory submissions. Oncology therapeutic expertise and industry experience are preferred. The role is based at the Redwood City, CA headquarters with a salary range of $261,000–$300,000, focusing on safety oversight for innovative targeted cancer therapies.