Associate Director, Medical Safety Science (Safety Scientist)

MISSIONMirum 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 SUMMARYMirum 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/RESPONSIBILITIESConduct Sponsor oversight from a safety science perspective, and assessment of ICSRs both in post-marketing and clinical trial settingGenerate outputs from the Safety Database as needed for aggregate reports and ad hoc requestsPerform coding review of adverse events and medical history in the clinical database for all Mirum products and studiesFacilitate and/or Author aggregate safety reports such as the DSUR, PADER, PSUR, etcRepresent Medical Safety Science in assigned clinical study team meetings for Mirum productsSupport the Sr. Director of Medical Safety in Safety Adjudication Meetings, as necessaryReview and develop Medical Safety Science SOPs and Work InstructionsSupport 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 reportsReview and revise medical safety science-related sections in study protocols, ICFs, and periodic reportsReview Safety-related documents such as Joint Operating Guidelines, Monthly ReportsPerforms vendor training for new products and/ or studiesMaintains expectedness trackers for RSIs/ labelsMaintain Safety templates such as targeted questionnaires or protocol safety reporting languageReview/ revise SMPs, SDEAs, applicable SOPs and related forms from a Medical Safety Science perspectiveWorks closely with Medical Safety Operations to provide scientific input on an as needed basisReview and assess literature search resultsSupports 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 SMEQUALIFICATIONSEducation /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-market setting, 5 years in a drug safety and pharmacovigilance role (specifically, as a Safety Scientist)Experience in safety surveillance activities (which includes but not limited to signal detection activities) is a mustExperience in authoring aggregate reports such as the DSUR, PSUR/ PBRER, PADER etc.Experience in AE and medical history coding review is required. MSSO-trained and UMC trained preferredSafety database and data entry experience preferred (Understands safety database structures and is familiar with data retrieval tools.)Experience as an SME for Safety Science in audits and inspectionsKnowledge, Skills and Abilities: Excellent interpersonal and communication skills, both written and oralUnderstanding of medical terminology and the ability to summarize medical information is preferredAttention to detail, critical thinking, and good organizational skillsThe ability to assess data and understand the medical/safety implicationsWork within a matrix environment and interact/communicate effectively across various levels within the organization when neededTeam player but can work independentlyThe salary range for this position is $215,000 to $230,000 USD. Compensation will be determined based on several factors including, but not limited to; skill set, years of experience, and the employee’s geographic location. Please note that the required compensation details listed in US role postings reflect the base salary only, and do not include bonus, equity, or benefits unless otherwise provided.#LI-HYBRIDMirum Pharmaceuticals is committed to Equal Employment Opportunity (EEO) and to compliance with all Federal, State and Local laws that prohibit employment discrimination on the basis of race, age, national origin, ethnicity, religion, gender, gender identity, pregnancy, marital status, sexual orientation, citizenship, genetic disposition or characteristics, disability, veteran’s status or any other classification protected by applicable State/Federal/Local laws.Mirum Pharmaceuticals provides reasonable accommodation for qualified individuals with disabilities and disabled veterans in job application procedures.