Associate Director, Medical Safety Science (Safety Scientist)

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-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 must
• Experience 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 preferred
• Safety 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 inspections

Knowledge, Skills and Abilities: 

• Excellent interpersonal and communication skills, both written and oral
• Understanding of medical terminology and the ability to summarize medical information is preferred
• Attention to detail, critical thinking, and good organizational skills
• The ability to assess data and understand the medical/safety implications
• Work within a matrix environment and interact/communicate effectively across various levels within the organization when needed
• Team player but can work independently

The 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.

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