Director, Drug Safety and Pharmacovigilance

Mavericks Wanted

When was the last time you achieved the impossible? If that thought feels overwhelming, you might want to pause here, but if it sparks excitement...read on

In 2015, we pioneered a “moneyball for biotech” approach, pooling projects and promising early-stage research from academia together under one financial umbrella to reduce risk and unleash innovation. This model allows science and small teams of experts to lead the way. We build bridges to groundbreaking advancements in rare disease, and develop life-changing medicines for patients with unmet needs as fast as humanly possible.

Together we define white space, push boundaries, and empower people to solve problems. If you're someone who defies convention, join us and work alongside some of the most respected minds in the industry. Together, we'll ask "why not?" and help reengineer the future of biopharma. At BridgeBio, we value curiosity and experimentation—including the ethical thoughtful use of AI to improve clarity, speed, and quality of work.

What You’ll Do

Serve as the business-side system owner and subject matter expert for the Veeva Safety platform, ensuring the system is compliantly configured, validated, and operationally effective in support of Eidos’ global pharmacovigilance program.

Responsibilities

Configure and administer the Veeva Safety platform (Vault Safety Suite: Safety, SafetyDocs, Signal, Workbench), including user administration, workflow routing, coding configurations (MedDRA, WHO Drug), and business rules

Author and execute validation documentation in accordance with 21 CFR Part 11, GxP, and GAMP 5 principles, including User Requirements Specifications (URS), IQ/OQ/PQ protocols, UAT scripts, and traceability matrices

Lead User Acceptance Testing (UAT) cycles for new releases, configuration changes, and system enhancements; maintain change control governance

Configure and run safety reports and operational dashboards within Veeva Safety; ensure all outputs are validated and fit for regulatory submission or internal review

Apply expert knowledge of the end-to-end adverse event lifecycle to inform system design and support case processing operations

Ensure system configuration supports compliance with global ICSR reporting timelines (7-day, 15-day) and periodic reporting frameworks (IND, NDA/PADER, PBRER/PSUR, DSUR)

Maintain current knowledge of worldwide pharmacovigilance regulations including ICH E2B(R2/R3), FDA, EMA, PMDA, and MHRA requirements; update system configurations accordingly

Oversee E2B(R3) gateway configurations for regulatory submissions to EudraVigilance, FDA ESG, and trading partners

Support PSMF maintenance activities related to PV system descriptions and IT infrastructure documentation

Develop and maintain system SOPs, work instructions, and user training materials; deliver training to system users

Lead inspection readiness activities related to the Veeva Safety system; support regulatory audits and agency inspections

Partner with IT, Quality, and Regulatory Affairs on system upgrades, integrations, and vendor governance

Where You’ll Work

This a U.S-based remote role that will require quarterly, or as needed visits to our San Francisco Office. Travel for unannounced Regulatory Authority Inspections is required.

Who You Are

Bachelor’s degree in life sciences, pharmacy, nursing, health informatics, or a related field required; advanced degree preferred

Minimum 8–10 years of experience in pharmacovigilance or drug safety operations within a pharmaceutical, biotechnology, or CRO environment

Demonstrated history of self-direction and accountability

Demonstrated Regulatory Agency Inspection history

Experience in both clinical trial and post-marketing safety required

Direct participation in agency inspections including FDA, EMA, Health Canada and others

Management of change management, compliance deviations, and CAPAs

Minimum 3–5 years of direct hands-on experience as a business administrator or power user on Veeva Safety (Vault Safety) or comparable safety database (Oracle Argus, 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

Experience with aggregate reporting frameworks: IND, NDA/PADER, PBRER/PSUR, DSUR, and CTPR

Experience with Veeva Safety migration projects (e.g., Argus-to-Veeva) a plus

Familiarity with AI/automation capabilities for AE processing and MedDRA coding within the Veeva ecosystem preferred

Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint, Outlook) required

Must be able and willing to travel

At BridgeBio, we strive to provide a market-competitive total rewards package, including base pay, an annual performance bonus, company equity, and generous health benefits. Below is the anticipated salary range for candidates for this role who will work in California. …