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Salary: USD 215,000 - 230,000 / annual
Mirum Pharmaceuticals, a biopharmaceutical company focused on rare disease treatments, is seeking an Associate Director of Medical Safety Science to join their Medical Safety team. This role reports to the Sr. Director of Medical Safety and involves comprehensive oversight of safety data across clinical trials and post-marketing settings.
Key responsibilities include conducting sponsor oversight and assessment of Individual Case Safety Reports (ICSRs) in both post-marketing and clinical trial environments. The successful candidate will generate outputs from safety databases for aggregate reports and ad hoc requests, perform coding review of adverse events and medical history in clinical databases, and author regulatory aggregate safety reports including DSURs, PADERs, and PSURs.
The role requires representing Medical Safety Science in clinical study team meetings, supporting safety adjudication meetings, and developing Medical Safety Science SOPs and work instructions. The candidate will lead safety surveillance and pharmacovigilance activities including signal detection, validation, and participation in Safety Review Team and Global Safety Committee meetings. Additional responsibilities include reviewing medical safety science sections in study protocols and informed consent forms, managing expectedness trackers for RSIs and labels, and serving as a subject matter expert for PV-specific inspection readiness and audits.
The ideal candidate will have a Bachelor's degree in a scientific discipline (RN, MS, or PharmD highly desired) with minimum 7 years of pharmaceutical or CRO experience, including at least 5 years specifically in drug safety and pharmacovigilance as a Safety Scientist. Required experience includes safety surveillance activities, signal detection, authoring aggregate reports, and AE/medical history coding review. MSSO and UMC training are preferred. Safety database experience and familiarity with data retrieval tools are advantageous.
Strong interpersonal and written/oral communication skills are essential, along with excellent attention to detail, critical thinking, and organizational abilities. The candidate must understand medical terminology, assess data for medical/safety implications, work effectively in matrix environments, and balance independent work with team collaboration.
