Associate Director, Medical Safety Science (Safety Scientist)

MISSION Mirum Pharmaceuticals is a biopharmaceutical company dedicated to transforming the treatment of rare diseases. We are passionate about advancing scientific discoveries to become important medicines for rare disease patients. We are collaborative, creative, and experienced professionals and we’re looking to augment our team with other individuals who embody our values: care, be real, get it done, and have fun, seriously.POSITION SUMMARY Mirum Pharmaceutical is seeking an Associate Director of Medical Safety Science (Safety Scientist). The ideal candidate will have experience in and perform multiple activities related to safety data review, document review, signal detection and management, authoring of aggregate reports and participating in multidisciplinary meetings. Successful candidate will report to Sr. Director, Medical Safety.  JOB FUNCTIONS/RESPONSIBILITIES Conduct Sponsor oversight from a safety science perspective, and assessment of ICSRs both in post-marketing and clinical trial setting Generate outputs from the Safety Database as needed for aggregate reports and ad hoc requests Perform coding review of adverse events and medical history in the clinical database for all Mirum products and studies Facilitate and/or Author aggregate safety reports such as the DSUR, PADER, PSUR, etc Represent Medical Safety Science in assigned clinical study team meetings for Mirum products Support the Sr. Director of Medical Safety in Safety Adjudication Meetings, as necessary Review and develop Medical Safety Science SOPs and Work Instructions Support safety surveillance/pharmacovigilance activities such as signal detection and validation, Safety Review Team meetings (SRT), and Global Safety Committee (GSC) meetings. This includes Signal monitoring/ tracking, scheduling of SRT and GST meetings, reviewing of meeting slides and signal detection reports Review and revise medical safety science-related sections in study protocols, ICFs, and periodic reports Review Safety-related documents such as Joint Operating Guidelines, Monthly Reports Performs vendor training for new products and/ or studies Maintains expectedness trackers for RSIs/ labels Maintain Safety templates such as targeted questionnaires or protocol safety reporting language Review/ revise SMPs, SDEAs, applicable SOPs and related forms from a Medical Safety Science perspective Works closely with Medical Safety Operations to provide scientific input on an as needed basis Review and assess literature search results Supports activities related to PV-specific inspection readiness by creating procedures and processes for Safety Science activities and participate in audits/inspections as the Safety Science SME QUALIFICATIONS Education /Experience: Bachelor’s degree in a scientific discipline is required. RN, MS (Master of Science) or PharmD degree is highly desired (coursework in clinical research preferred). Minimum 7 years in pharmaceutical or CRO experience in clinical trial or post-...