Manager, Safety Scientist

Role: Manager, Safety Scientist, supports compound safety evaluation and signal detection within pharmacovigilance, contributing to risk assessment, regulatory reporting, and safety data analysis. Responsibilities: perform signal detection, safety data evaluation, author safety assessments, support clinical trial safety monitoring, prepare safety documentation for regulatory submissions, and respond to health authority inquiries. Collaborates with Product Safety Leads, cross-functional teams, and safety committees, providing scientific insights and safety communication support. Requirements: PharmD, RN, or PhD/MS in medical or biological sciences; 2+ years in pharmacovigilance within the biopharma industry; experience with global regulatory requirements, safety data analysis, and safety databases (e.g., Argus). Preferred: knowledge of MedDRA, data mining tools (Spotfire, PowerBI), and familiarity with safety reporting and risk management plans. HighValue: supports oncology or cancer therapeutic programs, with a focus on safety evaluation, regulatory compliance, and signal management; less than 10% travel; global regulatory environment involvement. Work setup: remote or hybrid, with collaborative matrix team engagement.