Role Description 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.

Qualifications

• 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

• 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.
• People are part of our growth and success story - from discovery to active drug trials and FDA pipelines, there are endless opportunities for skill development and internal mobility.
• We provide career pathing through regular feedback, continuous education and professional development programs via LinkedIn Learning, LifeLabs, & BetterUp Coaching.
• We celebrate strong performance with financial rewards, peer-to-peer recognition, and growth opportunities.