Associate Director, Medical Safety Science (Safety Scientist)

Role: Associate Director of Medical Safety Science (Safety Scientist) at Mirum Pharmaceuticals, focusing on safety data review, signal detection, aggregate reporting, and pharmacovigilance activities for rare disease treatments. Responsibilities include overseeing safety assessments of ICSRs, generating safety database outputs, authoring aggregate safety reports (e.g., DSUR, PADER), reviewing adverse event coding, supporting safety surveillance and inspection readiness, and developing safety SOPs and safety-related documentation. The role involves collaboration with clinical study teams, safety operations, and participating in safety meetings and audits. Qualifications: Bachelor’s in a scientific discipline; RN, MS, or PharmD preferred; minimum 7 years in pharma or CRO with 5+ years in drug safety/pharmacovigilance; strong experience with safety surveillance, aggregate report writing, and adverse event coding; MSSO or UMC training desirable. Skills required include excellent communication, attention to detail, medical terminology understanding, and ability to operate within a matrix environment. High-value specifics: experience in post-marketing safety, signal detection, aggregate report authoring, and safety database systems. Work setup: likely hybrid or remote; salary range $215K-$230K, commensurate with experience.