Mirum Pharmaceuticals, Inc. · 11 hours ago
Associate Director, Medical Safety Review
Foster City
Full-time
Hybrid
Lead/Staff, Director/Executive
$210K/yr - $225K/yr
5+ years expMirum Pharmaceuticals is a biopharmaceutical company dedicated to transforming the treatment of rare diseases. They are seeking an Associate Director of Medical Safety Review to conduct medical reviews of ICSRs, evaluate safety data, and prepare aggregate reports.
BiotechnologyHealth CarePharmaceuticalTherapeutics
Responsibilities
Conduct medical review of ICSRs from any source including, but not limited to, clinical trials, literature, and post marketing reports
Confirm that events are correctly coded per MedDRA conventions
Review case narrative and medical content for completeness, identifying missing information that may impact medical understanding of the case, reviewing queries proposed by the Safety vendor, and issuing additional safety medical queries as needed
Review and approve Analysis of Similar Events (AOSE)
Provide overall case assessment and quality feedback to Safety vendor as part of sponsor oversight
Contribute to training, oversight monitoring, performance metrics review of Safety vendor activities where applicable
Support Safety Operations activities providing input on coding for SAE reconciliation, and other case processing questions from the medical review perspective
Generate outputs from the Safety Database 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
Support the authoring of aggregate safety reports such as DSUR, PADER, PBRER, etc
Review medical safety science-related sections in clinical and Regulatory documents
Review SMPs, SDEAs, applicable SOPs and related forms from a Medical Safety Science perspective
Review and assess literature search results
Supports activities related to PV-specific audit and inspection readiness
Qualification
Required
MD or RN degree with at least 5 years of pharmaceutical or CRO experience in clinical trial and post-marketing settings in a drug safety and pharmacovigilance role
Experience in medical review of ICSRs in clinical trial and post-marketing settings, including authoring of company comments and AOSE
Experience in MedDRA AE and medical history coding review is required
Working knowledge of the Safety and Clinical databases
Experience in the preparation of aggregate reports, Risk Management and Minimization programs
Experience in the preparation of safety aggregate reports
Excellent interpersonal and communication skills, both written and oral
Attention to detail and good organizational skills
The ability to assess data and understand the medical/safety implications
Team player but can work independently
Excellent working knowledge of pharmacovigilance and regulatory guidelines/ guidance
Ability to interact effectively with people of multiple disciplines and cultures both within and outside the company on a global basis
Preferred
Understanding of medical terminology and the ability to summarize medical information is preferred
Experience in rare diseases is a plus
Company
Mirum Pharmaceuticals, Inc.
Mirum Pharmaceuticals, Inc. is a biopharmaceutical company dedicated to transforming the treatment of rare diseases affecting children and adults.
201-500 employees
H1B Sponsorship
Mirum Pharmaceuticals, Inc. has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (1)
2024 (2)
2023 (1)
2022 (1)
2021 (1)
2020 (1)
Funding
Current Stage
Public CompanyTotal Funding
$765.5MKey Investors
TCG CrossoverOberland CapitalNew Enterprise Associates
2025-12-19Post Ipo Equity· $68.5M
2025-12-08Post Ipo Equity· $200M
2023-04-12Post Ipo Equity· $275M
Leadership Team
Joanne Quan
Chief Medical Officer
Recent News
2026-02-04
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2026-02-02
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2026-01-14
Company data provided by crunchbase