Senior Director, Drug Safety and Pharmacovigilance
About The Position
When was the last time you achieved the impossible? If that thought feels overwhelming, you might want to pause here, but if it sparks excitement...read on In 2015, we pioneered a “moneyball for biotech” approach, pooling projects and promising early-stage research from academia together under one financial umbrella to reduce risk and unleash innovation. This model allows science and small teams of experts to lead the way. We build bridges to groundbreaking advancements in rare disease, and develop life-changing medicines for patients with unmet needs as fast as humanly possible. Together we define white space, push boundaries, and empower people to solve problems. If you're someone who defies convention, join us and work alongside some of the most respected minds in the industry. Together, we'll ask "why not?" and help reengineer the future of biopharma. At BridgeBio, we value curiosity and experimentation—including the ethical & thoughtful use of AI to improve clarity, speed, and quality of work.
Requirements
- Bachelor’s degree in a health care discipline or equivalent is required, and an advanced degree is preferred
- At least 12 years of drug safety and pharmacovigilance experience (post-market safety experience in the biotechnology, pharmaceutical, drug safety contract service organization (CSO))
- 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
Responsibilities
- Accountable for maintenance of post market and clinical trial pharmacovigilance data systems for ICSR handling, periodic reporting, and safety inspection readiness
- 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
Benefits
- 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
- Career pathing through regular feedback, continuous education and professional development programs via LinkedIn Learning, LifeLabs, & BetterUp Coaching
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What This Job Offers
Job Type
Full-time
Career Level
Senior
