R&D VP

BridgeBio

VP of Drug Safety responsible for leading pharmacovigilance activities and managing drug safety operations. Collaborating with various stakeholders in the drug development process at BridgeBio Pharma.

Posted 6/12/2026full-time🇺🇸 United StatesLead💰 $420,000 - $460,000 per yearWebsite

About the role

Key responsibilities & impact

Contribute to and lead a full range of pharmacovigilance (PV) activities for investigational products, including operational activities, cross-functional activities with other departments, quality systems, audits, and inspections
Direct drug safety management oversight (clinical study case process flow, reconciliation with clinical database) for specific clinical trials, as requested
Manage oversight of external activities by vendors (CROs), including case processing, expedited safety reporting, and partner data exchange. The successful candidate will be responsible for oversight of safety operations strategy, including case management, database strategy, vendor oversight, compliance, inspection readiness, contracts, and training
Lead Safety section of submission documents
Participate and/or lead presentations with Regulatory Authorities
Participate and/or lead meetings with consultants and investigators
Participate and/or lead advisory panel meetings
Contribute to and review safety data exchange agreements with alliance partners and safety management documentation for studies managed under an alliance, as applicable
Develop proactive risk management strategies for investigational compounds
Provide updates of the assigned drug’s safety profile to senior management and recommend pharmacovigilance/risk management activities
Contribute to and review investigator’s brochures, safety sections of clinical study protocols, single and aggregate expedited reports, areas of regulatory submissions, or regulatory responses (including IRBs or Ethics Committees)
Plan, manage/perform and monitor all pharmacovigilance activities for assigned drug responsibilities, including:
Continuous monitoring and further development of the product safety profile
Safety issue management
Set-up of safety analyses in both clinical trial and post-marketing databases
Provide company causality assessments
Provide clinical input in signal detection and perform signal evaluation activities
Provide a clinical (drug safety) perspective at Safety Management Committee meetings
Participate in Bridgebio Safety Board when requested
Maintain currency with applicable PV global regulations and industry guidelines
Oversee preparation, development, implementation, and maintenance of company standard operating procedures and policies relating to pharmacovigilance and risk management to ensure compliance with ICH guidelines and applicable regulatory requirements
Contribute to inspection readiness activities
Develop strategies to further enhance and optimize the impact of the Drug Safety and PV department

Requirements

What you’ll need

Post-graduate degree (MD, DO) or international equivalent from an accredited institution
Excellent communication and interpersonal skills
Minimum of 12 years of relevant industry experience, which includes at least 9 years of senior drug safety experience
Must have experience in both clinical development and post-marketing drug safety
Must have Regulatory Submission experience
Minimum of One (1) to three (3) years of project leadership/management experience
Experience writing safety sections of marketing applications, integrated safety summary, DSUR/PSUR preferred
Excellent and broad understanding of the pharmaceutical industry and the future trends and developments in pharmacovigilance
Management Experience preferred
Must have safety experience in multiple therapeutic areas
Completion of a US residency or ex-US equivalent

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

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Applicant Tracking System Keywords

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Hard Skills & Tools

pharmacovigilancedrug safety managementcase processingexpedited safety reportingrisk management strategiessignal detectionsafety analysessafety issue managementclinical inputregulatory submissions

Soft Skills

communication skillsinterpersonal skillsleadershipproject managementpresentation skillscollaborationstrategic thinkingproblem-solvingtrainingreviewing

Certifications

post-graduate degree (MD, DO)US residency or ex-US equivalent