New · posted Oct 31
Mirum Pharmaceuticals · Pharmaceuticals
Senior Vice President, Drug Safety and Pharmacovigilance
- Foster City, CA
- Hybrid
- Full-time
- VP & Executive
The role
The SVP of Drug Safety and Pharmacovigilance will provide the leadership and management for the infrastructure and functioning of the Drug Safety and Pharmacovigilance department across both clinical development and commercial products for the company. The SVP leads the department and also works collaboratively across a team of peers in Clinical, Regulatory, Biometrics, Medical Affairs and Commercial and will be accountable for ensuring safety systems, staff and procedures are in place to support a compliant global pharmacovigilance system. The SVP of Drug Safety & Pharmacovigilance will interface with vendors, external experts, business partners, investigators, and government agencies.
MISSION
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 and we’re looking to augment our team with other individuals who embody our values: care, be real, get it done, and have fun, seriously.
What you need
Education /Experience
- MD, PharmD or equivalent degree
- Minimum of fifteen (15+) years Pharmacovigilance experience with at least five (5) years of department management experience
- Experience in building teams, directly or matrixed and leading projects
- Experience in risk management strategies and signal detection strategies
- Robust knowledge of global PV requirements
- Experience overseeing safety/PV vendors
- Experience with regulatory authority inspections
- Ability to provide robust safety strategies at the highest level as well as perform detailed work to support Phase 1-3 programs, as well as commercial products
- Strong business acumen and ability to negotiate and collaborate with cross-functional partners to achieve department and company goals
- Effective written, verbal communication and interpersonal, relationship-building skills
- Proven professional track record of strategic, organizational, and executional skills to support project planning across multiple activities, with the ability to anticipate and prioritize team workload on multiple ongoing projects
- Organized, attention to detail, and able to meet timelines in a fast-paced environment
- Able to work with a high level of autonomy and independence
- Knowledge and understanding of global regulatory requirements for product approval and compliance
Where you'll work
Foster City, CAHybridOpen in Maps (opens in a new tab)
More jobs in Foster City, CAWorking conditions
JOB FUNCTIONS/RESPONSIBILITIES
- Oversee the Mirum global PV system to enable compliance with global PV regulatory requirements
- Creation of organizational strategy, goals and objectives for the department and ensure implementation of business plans to support both US and international global safety strategies
- Maintain awareness of new and emerging safety concerns and related communications to the competent authorities in a time frame appropriate to the benefit-risk assessment of Mirum’s products
- Responsible for all medical safety aspects of clinical development and post market surveillance of medicinal products in the Mirum portfolio
- Strategic oversight and overall responsibility of commercial safety reporting requirements for US, EU and other international territories, as required.
- Management, oversight and mentorship of staff able to set the strategy for future Drug Safety & PV department build and planning
- Partner with clinical development representatives to lead safety signal assessments and validate safety signals
- Communicate important safety information to appropriate stakeholders, including executive management, as appropriate
- Participate in health authority interactions (both written and verbal) and inspections regarding safety risk management; oversees team members who support such interactions
- Oversight of Drug Safety Committees & Core Safety Information
- Contribute written summaries and provide safety review for safety components of protocols, IB, clinical study reports, regulatory submissions, label negotiations etc. by working directly with team members and offering strategic and tactical support when needed
- Oversee, Write or Review of periodic aggregate/safety reports
- Perform Benefit-Risk Assessments in collaboration with Clinical Development, as required
- Ensure compliance with global safety requirements and inspection readiness, including root-cause analyses
- Manage relationships with clients and team members providing expert safety knowledge
- Support the evaluation of business opportunities, as directed by executive management
Equal opportunity, accessibility and legal noticesMirum Pharmaceuticals's statements, word for word
Mirum Pharmaceuticals is committed to Equal Employment Opportunity (EEO) and to compliance with all Federal, State and Local laws that prohibit employment discrimination on the basis of race, age, national origin, ethnicity, religion, gender, gender identity, pregnancy, marital status, sexual orientation, citizenship, genetic disposition or characteristics, disability, veteran’s status or any other classification protected by applicable State/Federal/Local laws.
Mirum Pharmaceuticals provides reasonable accommodation for qualified individuals with disabilities and disabled veterans in job application procedures.
Job intelligence
The context around this role
Live data · October 31, 2026
Salary intelligence
How the pay compares
VP & Executive roles in the US10 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| All US (middle half) | $346,500 | $346,500 | $353,125 |
Comparisons: the base pay employers published on open Clinical Safety & Pharmacovigilance roles at the same level on Regulatory Jobs, October 31, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Clinical Safety & Pharmacovigilance
The general path across 113 open Clinical Safety & Pharmacovigilance roles on Regulatory Jobs, with the titles they carry most. Not Mirum Pharmaceuticals's own promotion track.
Skills DNA
What this role leans on
How many of the posting's 16 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- Collaboration and leadership6
- GMP and compliance2
- Documentation and SOPs2
- Investigations and CAPA1
- Quality systems and risk1
- Clinical trial conduct1
Company hiring pulse
Mirum Pharmaceuticals on Regulatory Jobs
- 9
- Open roles
- 9
- Distinct roles
- 1
- Locations
By discipline
- Regulatory5 56%
- Quality2 22%
- Clinical2 22%
By level
- Director5 56%
- VP & Executive2 22%
- Manager1 11%
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Senior Vice President, Drug Safety and Pharmacovigilance at Mirum Pharmaceuticals
Open until filled.