Director, Drug Safety and Pharmacovigilance

Responsibilities

• Serve as the business-side system owner and subject matter expert for the Veeva Safety platform to support global pharmacovigilance programs.
• Configure and administer the Veeva Safety platform (Vault Safety Suite), including user administration, workflow routing, and coding configurations (MedDRA, WHO Drug).
• Author and execute validation documentation in accordance with 21 CFR Part 11, GxP, and GAMP 5 principles, including URS, IQ/OQ/PQ, and UAT scripts.
• Lead User Acceptance Testing (UAT) cycles for new releases, configuration changes, and system enhancements.
• Ensure system configuration supports compliance with global ICSR reporting timelines and periodic reporting frameworks (IND, NDA, PBRER, DSUR).
• Oversee E2B(R3) gateway configurations for regulatory submissions to EudraVigilance, FDA ESG, and other trading partners.
• Lead inspection readiness activities related to the Veeva Safety system and support regulatory audits and agency inspections.
• Develop and maintain system SOPs, work instructions, and user training materials.

Requirements

• Bachelor’s degree in life sciences, pharmacy, nursing, health informatics, or a related field.
• 8–10 years of experience in pharmacovigilance or drug safety operations within a pharmaceutical, biotechnology, or CRO environment.
• 3–5 years of direct hands-on experience as a business administrator or power user on Veeva Safety (Vault Safety) or comparable safety databases like Oracle Argus or ARISg.
• Demonstrated experience authoring and executing GxP validation documentation (URS, IQ/OQ/PQ, UAT) in a regulated environment.
• Deep knowledge of ICH E2B(R2/R3), MedDRA, WHO Drug coding, and global ICSR reporting requirements.
• Proven history of participating in and supporting regulatory agency inspections (FDA, EMA, etc.).
• Experience in both clinical trial and post-marketing safety.

Preferred Qualifications

• Advanced degree in a relevant scientific or health field.
• Experience with Veeva Safety migration projects (e.g., Argus-to-Veeva).
• Familiarity with AI/automation capabilities for AE processing and MedDRA coding within the Veeva ecosystem.

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.
• Fertility and family-forming benefits.

About the Company

BridgeBio is a biopharmaceutical company that uses a unique "moneyball for biotech" approach to accelerate the development of life-changing medicines for patients with rare diseases and unmet medical needs. We value curiosity, experimentation, and the empowerment of experts to solve complex problems.