About the role
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
As a global company, our comprehensive benefits may vary based on location. We have high expectations for our team members. We make sure those working hard for patients are rewarded and cared for in return.
For Full-Time U.S Based Roles:
Financial & Rewards
- Market-leading compensation
- 401(k) with employer match
02 Aplyr's read
BridgeBio Pharma is a dynamic biotechnology firm dedicated to tackling genetic diseases and cancers, attracting professionals passionate about impactful medical advancements.
What's promising
- •BridgeBio focuses on innovative treatments for genetic diseases, offering significant potential for groundbreaking medical advancements.
- •The company has a robust pipeline with multiple late-stage clinical trials, indicating strong future growth prospects.
- •BridgeBio's strategic partnerships enhance its research capabilities and expand its therapeutic reach.
What to watch
- •The company faces high financial risk due to significant R&D expenditures without guaranteed success.
- •BridgeBio operates in a highly competitive market with numerous established players.
- •Regulatory hurdles for drug approvals can delay product launches and impact revenue.
Why BridgeBio Pharma
- •BridgeBio's focus on genetic diseases and cancers sets it apart in the biotechnology sector.
- •The company's decentralized model allows for nimble and efficient project management.
- •BridgeBio's commitment to rare diseases addresses unmet medical needs, differentiating its mission.
Aplyr’s read is generated by AI from public sources. Was it useful?
03 About BridgeBio Pharma
BridgeBio is a biotechnology company focused on developing and commercializing medicines for genetic diseases and cancers.
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