BridgeBio Pharma - Senior Director, Drug Safety and Pharmacovigilance
Requirements
• 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 • At BridgeBio, we strive to provide a market-competitive total rewards package, including base pay, an annual performance bonus, company equity, and generous health benefits. Below is the anticipated salary range for candidates for this role who will work in California. The final salary offered to a successful candidate will depend on several factors that may include but are not limited to the type and length of experience within the job, type, and length of experience within the industry, educational background, location of residence and performance during the interview process. BridgeBio is a multi-state employer, and this salary range may not reflect positions based in other states. • $250,000—$289,000 USD • As a global company, our comprehensive benefits may vary based on location. We have high expectations for our team members. We make sure those working hard for patients are rewarded and cared for in return. • For Full-Time U.S Based Roles:
Responsibilities
• Serve as the business-side system owner and subject matter expert for the Veeva Safety platform, ensuring the system is compliantly configured, validated, and operationally effective in support of Eidos’ global pharmacovigilance program. • Configure and administer the Veeva Safety platform (Vault Safety Suite: Safety, SafetyDocs, Signal, Workbench), including user administration, workflow routing, coding configurations (MedDRA, WHO Drug), and business rules • Author and execute validation documentation in accordance with 21 CFR Part 11, GxP, and GAMP 5 principles, including User Requirements Specifications (URS), IQ/OQ/PQ protocols, UAT scripts, and traceability matrices • Lead User Acceptance Testing (UAT) cycles for new releases, configuration changes, and system enhancements; maintain change control governance • Configure and run safety reports and operational dashboards within Veeva Safety; ensure all outputs are validated and fit for regulatory submission or internal review • Ensure system configuration supports compliance with global ICSR reporting timelines (7-day, 15-day) and periodic reporting frameworks (IND, NDA/PADER, PBRER/PSUR, DSUR) • Maintain current knowledge of worldwide pharmacovigilance regulations including ICH E2B(R2/R3), FDA, EMA, PMDA, and MHRA requirements; update system configurations accordingly • Oversee E2B(R3) gateway configurations for regulatory submissions to EudraVigilance, FDA ESG, and trading partners • Support PSMF maintenance activities related to PV system descriptions and IT infrastructure documentation • Develop and maintain system SOPs, work instructions, and user training materials; deliver training to system users • Lead inspection readiness activities related to the Veeva Safety system; support regulatory audits and agency inspections • Partner with IT, Quality, and Regulatory Affairs on system upgrades, integrations, and vendor governance • Where You’ll Work • Where You’ll Work • This a U.S-based remote role that will require quarterly, or as needed visits to our San Francisco Office. Travel for unannounced Regulatory Authority Inspections is required.
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 • Referral bonus • Subsidized lunch and parking on in-office days • Subsidized lunch and parking • Health & Well-Being • Health & Well-Being • 100% employer-paid medical, dental, and vision premiums for you and your dependents • 100% employer-paid medical, dental, and vision premiums • Health Savings Account (HSA) with annual employer contributions, plus Flexible Spending Accounts (FSA) • Health Savings Account (HSA) • Flexible Spending Accounts (FSA) • Fertility & family-forming benefits • Expanded mental health support (therapy and coaching resources) • Expanded mental health support • Hybrid work model with flexibility • Hybrid work model • Flexible, “take-what-you-need” paid time off and company-paid holidays • Flexible, “take-what-you-need” paid time off • Comprehensive paid medical and parental leave to care for yourself and your family • Comprehensive paid medical and parental leave • Skill Development & Career Paths: • 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
Apply in one click
Upload My Resume
Drop here or click to browse · Tap to choose · PDF, DOCX, DOC, RTF, TXT