Senior 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** - Accountable for maintenance of post market and clinical trial pharmacovigilance data systems for ICSR handling, periodic reporting, and safety inspection readiness **Responsibilities** - The primary responsibilities are to manage safety contract service organizations (CSOs) with >=95% compliance with clinical and postmarket safety regulations (including to the FDA, EMA, MHRA, and all assigned international RAs), processes, PV agreements, and database management - Oversee safety CSOs for postmarket programs to achieve global safety systems to meet corporate goals and key performance indicators - Accountable for maintaining AE intake from global data sources including Organized Data Collection Systems - Develop and prepare assessments of global safety data analyses for internal senior leadership as well as external partner or regulatory authorities - Maintain audit trail as inspection ready at all times - When requested, work with other BridgeBio Affiliates to provide strategic input and work on assigned non-product/compound-related projects **Where You’ll Work** This a U.S-based remote role that will require quarterly, or as needed visits to our San Francisco Office. **Who You Are** - Bachelor’s degree in a health care discipline or equivalent is required, and an advanced degree is preferred - Requires at least 12 years of drug safety and pharmacovigilance experience (post-market safety experience in the biotechnology, pharmaceutical, drug safety contract service organization (CSO)) - Requires at least three years of PV business management of safety systems leading maintenance and regulatory agency inspections - Demonstrated history of self-direction and accountability, demonstrated during Inspection history - Experience with regulatory submissions for PSUR, PBRER, RMP; experience in US, EU Canada, Brazil, Australia preferred - 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 - Expertise with clinical trial and post market safety database use, management, and change control (Argus, ArisG, and/or VeevaSafety) and Microsoft Office Suite required (Word, Excel, PowerPoint, Project, Outlook) - 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. The final salary offered to a successful candidate will depend on several factors that may include but are not limited to the type and length of experience within the job, type, and length of experience within the industry, educational background, location of residence and performance during the interview process. BridgeBio is a mult…