Mirum Pharmaceuticals, Inc. · 5 hours ago
Associate Director, Medical Safety Science
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 Science to conduct medical reviews, evaluate safety data, and support pharmacovigilance activities.
BiotechnologyHealth CarePharmaceuticalTherapeutics
Responsibilities
Conduct medical review of ICSRs from any source including, but not limited to, clinical trials, literature, and post marketing reports
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
Represent Medical Safety Science in clinical study team meetings for the assigned Mirum products
Review and develop Medical Safety Science SOPs and Work Instructions
Contribute to the development of risk management plans and REMs as needed
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, drafting of signal detection reports
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, RN, or PharmD 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
The Motley Fool
2026-01-14
2026-01-13
Company data provided by crunchbase