Director, Drug Safety & Pharmacovigilance

Role Summary

Director, Drug Safety & Pharmacovigilance. Lead all aspects of drug safety functions for US and assigned postmarketing data review and reporting. Oversee CSOs for postmarket pharmacovigilance to ensure compliance and timely safety reporting. Develop global safety assessments and manage relationships with internal/external stakeholders, including regulatory authorities.

Responsibilities

• Accountable for maintenance and inspection readiness of the quality management system for signal management and PBRER preparation
• Lead data collection for signal examination and assessment within timelines
• Coordinate ad hoc safety review meetings with stakeholders, ensuring 100% timely signal evaluation and audit trails
• Author aggregate reports including PBRER and other local safety reports
• Collaborate with partner for global risk management plans
• Manage PV agreements and compliance for local distribution organizations; ensure audit trail is inspection ready
• Oversee creation of periodic and signal management reports, analyses, and safety data presentations
• Reconcile incoming safety information with safety databases
• Prepare reports for company management and external regulatory agencies
• Ensure compliance with SOPs and global drug safety regulations (FDA, EMA, MHRA, etc.)
• Implement pharmacovigilance SOPs and timely processing of adverse event data across programs
• Collaborate with BridgeBio Affiliates on strategic input for non-product-related projects when requested

Qualifications

• Bachelor‚Äôs degree in a health care discipline required; advanced degree preferred
• At least ten years of drug safety and pharmacovigilance experience, with three years of oversight management
• Experience in post-marketing safety and clinical development; regulatory submissions for PSUR, PBRER, RMP; experience in US/EU/Canada/Brazil/Australia preferred
• QPPV service management and PSMF authoring experience
• Direct FDA/EMA (and other regulatory bodies) inspection experience
• Experience growing a clinical trial safety system into a global post-marketing PV system
• Proven ability to manage drug safety teams or CROs for ICSR, expedited reporting, PSURs, and KPI achievement
• Strong safety signal management and regulatory documentation experience
• GCP knowledge and working familiarity with FDA/ICH guidelines

Skills

• Safety data analysis and signal detection
• Regulatory submissions and inspection readiness
• Vendor/CRO management and contract oversight
• Cross-functional collaboration and stakeholder management
• Quality management and compliance in pharmacovigilance

Education

• Bachelor‚Äôs degree in a health care discipline; advanced degree preferred

Additional Requirements

• Remote role based in the U.S. with quarterly or as-needed visits to San Francisco office