Associate Director, Medical Safety Science (Safety Scientist)

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 looking to augment our team with individuals who embody our values: care, be real, get it done, and have fun, seriously.

About the role

The Associate Director of Medical Safety Science (Safety Scientist) will perform multiple activities related to safety data review, document review, signal detection and management, authoring of aggregate reports, and participating in multidisciplinary meetings. The successful candidate will report to the Sr. Director of Medical Safety.

Responsibilities

• Conduct Sponsor oversight from a safety science perspective and assess Individual Case Safety Reports (ICSRs) in both post-marketing and clinical trial settings.
• 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 (SRT) meetings, and Global Safety Committee (GSC) meetings. This includes signal monitoring/tracking, scheduling of SRT and GSC meetings, reviewing meeting slides, and signal detection reports.
• Review and revise medical safety science-related sections in study protocols, Informed Consent Forms (ICFs), and periodic reports.
• Review safety-related documents such as Joint Operating Guidelines and Monthly Reports.
• Perform vendor training for new products and/or studies.
• Maintain expectedness trackers for Reference Safety Information (RSIs)/labels.
• Maintain safety templates such as targeted questionnaires or protocol safety reporting language.
• Review/revise Safety Management Plans (SMPs), Safety Data Exchange Agreements (SDEAs), applicable SOPs, and related forms from a Medical Safety Science perspective.
• Work closely with Medical Safety Operations to provide scientific input as needed.
• Review and assess literature search results.
• Support activities related to pharmacovigilance-specific inspection readiness by creating procedures and processes for Safety Science activities and participate in audits/inspections as the Safety Science Subject Matter Expert (SME).

Requirements

• 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, with 5 years in a drug safety and pharmacovigilance role (specifically as a Safety Scientist).
• Experience in safety surveillance activities (including signal detection activities) is required.
• Experience in authoring aggregate reports such as DSUR, PSUR/PBRER, PADER, etc.
• Experience in adverse event 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.

Skills

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

Pay

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.