Sr. Medical Director, Drug Safety and Pharmacovigilance

Join BridgeBio as a Sr. Medical Director, Drug Safety and Pharmacovigilance to lead the risk management and safety strategy for assigned products, including internal and external collaboration and regulatory engagement.

Requirements

• Medical Degree
• 12 years of drug safety and pharmacovigilance experience
• 2 years of oversight management experience
• Extensive experience with safety signal evaluation
• Experience in clinical development and post-marketing safety
• Regulatory submissions for NDAs, EU MAAs, and other countries' Regulatory reviews
• Drug safety audits and agency inspections
• GCP, FDA, Good Clinical Practices, and ICH regulations and guidelines
• Microsoft Office Suite
• CIOMS II and DSUR reporting generation (Argus, ArisG, or VeevaSafety)

Benefits

• Market leading compensation
• 401K with 100% employer match
• Employee stock purchase program
• Pre-tax commuter benefits
• Referral program
• Comprehensive health care
• Mental health support
• Hybrid work model
• Unlimited flexible paid time off
• Paid parental leave
• Flex spending accounts
• Group term life & disability
• Subsidized lunch