VP of Drug Safety

Responsibilities

• Lead a full range of pharmacovigilance (PV) activities for investigational products, including operational activities, quality systems, audits, and inspections
• Manage oversight of external activities by CROs, including case processing, expedited safety reporting, and partner data exchange
• Direct drug safety management oversight for specific clinical trials, including clinical study case process flow and database reconciliation
• Lead the Safety section of regulatory submission documents and participate in presentations with Regulatory Authorities
• Develop proactive risk management strategies and provide clinical input in signal detection and evaluation
• Oversee the preparation, implementation, and maintenance of company standard operating procedures (SOPs) relating to pharmacovigilance
• Provide updates on assigned drug safety profiles to senior management and recommend necessary risk management activities

Requirements

• MD or DO degree (or international equivalent) from an accredited institution
• Completion of a US residency or equivalent
• Minimum of 12 years of relevant industry experience, including at least 9 years of senior drug safety experience
• Proven experience in both clinical development and post-marketing drug safety
• Direct experience with Regulatory Submissions
• 1–3 years of project leadership or management experience
• Experience in multiple therapeutic areas

Preferred Qualifications

• Experience writing safety sections of marketing applications, integrated safety summaries, DSUR, or PSUR
• Prior management experience

Benefits

• Market-leading compensation and annual performance bonuses
• 100% employer-paid medical, dental, and vision premiums for employees and dependents
• 401(k) with employer match and Employee Stock Purchase Program (ESPP)
• Flexible, “take-what-you-need” paid time off and comprehensive parental leave
• Hybrid work model with flexibility

About the Company

BridgeBio is a biopharmaceutical company that uses a unique "moneyball for biotech" approach to reduce risk and accelerate innovation. We build bridges to groundbreaking advancements in rare diseases, developing life-changing medicines for patients with unmet needs as fast as humanly possible.