Senior Director, Drug Safety and Pharmacovigilance

BridgeBio

Senior Director overseeing drug safety and pharmacovigilance at BridgeBio Pharma. Responsible for compliance, data analysis, and regulatory interactions in biotechnology.

Posted 6/17/2026full-timeCalifornia • 🇺🇸 United StatesSenior💰 $250,000 - $289,000 per yearWebsite

About the role

Key responsibilities & impact

Accountable for maintenance of post market and clinical trial pharmacovigilance data systems for ICSR handling, periodic reporting, and safety inspection readiness
The primary responsibilities are to manage safety contract service organizations (CSOs) with >=95% compliance with clinical and postmarket safety regulations (including to the FDA, EMA, MHRA, and all assigned international RAs), processes, PV agreements, and database management
Oversee safety CSOs for postmarket programs to achieve global safety systems to meet corporate goals and key performance indicators
Accountable for maintaining AE intake from global data sources including Organized Data Collection Systems
Develop and prepare assessments of global safety data analyses for internal senior leadership as well as external partner or regulatory authorities
Maintain audit trail as inspection ready at all times
When requested, work with other BridgeBio Affiliates to provide strategic input and work on assigned non-product/compound-related projects

Requirements

What you’ll need

Bachelor’s degree in a health care discipline or equivalent is required, and an advanced degree is preferred
Requires at least 12 years of drug safety and pharmacovigilance experience (post-market safety experience in the biotechnology, pharmaceutical, drug safety contract service organization (CSO))
Requires at least three years of PV business management of safety systems leading maintenance and regulatory agency inspections
Demonstrated history of self-direction and accountability, demonstrated during Inspection history
Experience with regulatory submissions for PSUR, PBRER, RMP; experience in US, EU Canada, Brazil, Australia preferred
Experience in both clinical trial and post-marketing safety required
Direct participation in agency inspections including FDA, EMA, Health Canada and others
Management of change management, compliance deviations, and CAPAs
Expertise with clinical trial and post market safety database use, management, and change control (Argus, ArisG, and/or VeevaSafety) and Microsoft Office Suite required (Word, Excel, PowerPoint, Project, Outlook)
Must be able and willing to travel

Benefits

Comp & perks

Market-leading compensation
401(k) with employer match
Employee Stock Purchase Program (ESPP)
Pre-tax commuter benefits (transit and parking)
Referral bonus for hired candidates
Subsidized lunch and parking on in-office days
100% employer-paid medical, dental, and vision premiums for you and your dependents
Health Savings Account (HSA) with annual employer contributions, plus Flexible Spending Accounts (FSA)
Fertility & family-forming benefits
Expanded mental health support (therapy and coaching resources)
Hybrid work model with flexibility
Flexible, “take-what-you-need” paid time off and company-paid holidays
Comprehensive paid medical and parental leave to care for yourself and your family

ATS Keywords

✓ Tailor your resume

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools

pharmacovigilancedrug safetyregulatory submissionsdata analysischange managementcompliance deviationsCAPAssafety systems managementclinical trial safetypost-marketing safety

Soft Skills

self-directionaccountabilitystrategic inputleadership