Associate Director, Medical Safety Science (Safety Scientist)
Mirum Pharmaceuticals, Inc.
August 06, 2026
Remote friendly (Foster City, CA)
United States
Medical Affairs
Associate Director of Medical Safety Science (Safety Scientist)
Position Summary
- Perform safety data review, document review, signal detection and management, authoring aggregate reports, and participate in multidisciplinary meetings. Reports to Sr. Director, Medical Safety.
Job Functions/Responsibilities
- Conduct sponsor oversight and assess ICSRs in post-marketing and clinical trial settings
- Generate outputs from the Safety Database for aggregate reports and ad hoc requests
- Perform AE and medical history coding review in the clinical database
- Facilitate and/or author aggregate safety reports (DSUR, PADER, PSUR, etc.)
- Represent Medical Safety Science in clinical study team meetings
- Support safety adjudication meetings as needed
- Review/develop Medical Safety Science SOPs and Work Instructions
- Support safety surveillance/pharmacovigilance (signal detection/validation, SRT, GSC; monitor/track signals; review slides/reports)
- Review/revise safety sections in protocols, ICFs, and periodic reports
- Review safety-related documents (e.g., Joint Operating Guidelines, Monthly Reports)
- Perform vendor training; maintain expectedness trackers and safety templates
- Review/revise SMPs, SDEAs, and related SOPs/forms
- Work with Medical Safety Operations for scientific input; review literature search results
- Support PV inspection readiness as Safety Science SME
Qualifications
- Bachelor’s degree in a scientific discipline required; RN, MS, or PharmD highly desired
- Minimum 7 years in pharma/CRO clinical trial or post-market setting; 5 years in drug safety/pharmacovigilance as a Safety Scientist
- Safety surveillance (including signal detection) required
- Experience authoring aggregate reports (DSUR, PSUR/PBRER, PADER, etc.)
- AE and medical history coding review required (MSSO-trained and UMC trained preferred)
- Safety database/data entry experience preferred
- SME experience in audits/inspections
Skills/Abilities
- Excellent written/oral communication; medical terminology understanding
- Attention to detail, critical thinking, organizational skills
- Ability to assess data and medical/safety implications
- Effective in matrix environments; team player with independent work ability
Compensation
- Salary range: $215,000–$230,000 USD (base salary; bonus/equity/benefits not included unless otherwise provided).
Position Summary
- Perform safety data review, document review, signal detection and management, authoring aggregate reports, and participate in multidisciplinary meetings. Reports to Sr. Director, Medical Safety.
Job Functions/Responsibilities
- Conduct sponsor oversight and assess ICSRs in post-marketing and clinical trial settings
- Generate outputs from the Safety Database for aggregate reports and ad hoc requests
- Perform AE and medical history coding review in the clinical database
- Facilitate and/or author aggregate safety reports (DSUR, PADER, PSUR, etc.)
- Represent Medical Safety Science in clinical study team meetings
- Support safety adjudication meetings as needed
- Review/develop Medical Safety Science SOPs and Work Instructions
- Support safety surveillance/pharmacovigilance (signal detection/validation, SRT, GSC; monitor/track signals; review slides/reports)
- Review/revise safety sections in protocols, ICFs, and periodic reports
- Review safety-related documents (e.g., Joint Operating Guidelines, Monthly Reports)
- Perform vendor training; maintain expectedness trackers and safety templates
- Review/revise SMPs, SDEAs, and related SOPs/forms
- Work with Medical Safety Operations for scientific input; review literature search results
- Support PV inspection readiness as Safety Science SME
Qualifications
- Bachelor’s degree in a scientific discipline required; RN, MS, or PharmD highly desired
- Minimum 7 years in pharma/CRO clinical trial or post-market setting; 5 years in drug safety/pharmacovigilance as a Safety Scientist
- Safety surveillance (including signal detection) required
- Experience authoring aggregate reports (DSUR, PSUR/PBRER, PADER, etc.)
- AE and medical history coding review required (MSSO-trained and UMC trained preferred)
- Safety database/data entry experience preferred
- SME experience in audits/inspections
Skills/Abilities
- Excellent written/oral communication; medical terminology understanding
- Attention to detail, critical thinking, organizational skills
- Ability to assess data and medical/safety implications
- Effective in matrix environments; team player with independent work ability
Compensation
- Salary range: $215,000–$230,000 USD (base salary; bonus/equity/benefits not included unless otherwise provided).