BridgeBio · 11 hours ago
Sr. Director/Safety Scientist, Pharmacovigilance Operations
United States
Full-time
Remote
Director/Executive
$248K/yr - $285K/yr
10+ years expBridgeBio is a pioneering biotech company that focuses on developing innovative therapies for rare diseases. The Sr. Director/Safety Scientist will oversee the safety profile of assigned products throughout clinical development and post-approval, ensuring compliance and managing relationships with CROs and regulatory authorities.
BiotechnologyHealth CareLife ScienceMedicalPharmaceutical
Responsibilities
Oversight and understanding of all aspects of the assigned product’s safety profile from clinical development to post-approval safety surveillance, including management of CROs and other partners that provide clinical and safety data
Facilitate Safety Management Committee for designated product(s), responsible for identifying any emerging safety trends, defining the safety profile, and recommending safety actions based upon cumulative safety data
In collaboration with the regulatory and clinical development team, establish the safety strategy for marketing authorization applications, including the preparation of CTD documents, engagement with regulatory authorities, and authoring responses to inquiries
Support the clinical development team in the review of key documents, including protocols and informed consent forms (ICFs)
Manage drug safety contract research organizations (CROs) for clinical programs to ensure compliance with expedited reporting requirements, on-time and scientifically sound DSUR preparation, and alignment with corporate goals and KPIs
Assist in the medical review of adverse event reports; manage preparation and submission of expedited safety reports in compliance with global regulations, when necessary
Develop and prepare assessments of safety data, safety signals, and benefit-risk evaluations for internal senior management as well as external partners and regulatory authorities
Assist in the authoring of aggregate safety reports
Qualification
Required
Bachelor's degree in a healthcare discipline or equivalent is required; an advanced degree is preferred
Minimum of ten years of drug safety and pharmacovigilance experience, including at least five years in clinical development safety
Extensive experience with all aspects of safety signal evaluation, including data review and analysis, cross-functional collaboration, authoring regulatory correspondence, and safety label updates
Experience in both clinical development and post-marketing safety
Intimate knowledge of GCP and strong working knowledge of FDA regulations, ICH guidelines, and global pharmacovigilance requirements
Proven ability to collaborate successfully with clinical trial teams, including data management, clinical sciences, medical monitoring, clinical operations, biostatistics, regulatory affairs, medical writing, and quality assurance
Experience managing clinical safety aspects of product quality defect investigations and assessments
Familiarity with clinical trial safety databases and CIOMS II and DSUR reporting (e.g., Argus, ArisG, or Veeva Safety) and proficiency with Microsoft Office Suite (Word, Excel, PowerPoint, Project, Outlook)
Preferred
Experience with regulatory submissions for NDAs, EU MAAs, and other global regulatory reviews is highly preferred
Experience in drug safety audits and regulatory agency inspections
Benefits
401(k) with 100% employer match on the first 3% and 50% match on the next 2%
Employee stock purchase program
Pre-tax commuter benefits
Referral program with a $2,500 award for hired referrals
Comprehensive health coverage with 100% of premiums covered for employees and dependents
Mental health support via Spring Health (6 therapy sessions and 6 coaching sessions)
Hybrid work model with flexibility in where and how work is performed
Unlimited flexible paid time off
Paid parental leave: 4 months for birthing parents and 2 months for non-birthing parents
Flexible spending accounts and company-provided group term life and disability insurance
Subsidized lunches via Forkable on in-office days
Opportunities for growth from discovery through late-stage development and FDA pipelines
Career pathing through regular feedback, professional development programs, and continuous education via LinkedIn Learning, LifeLabs, Spring Health, and BetterUp Coaching
Recognition of strong performance through financial rewards, peer recognition, and advancement opportunities
Company
BridgeBio
BridgeBio focuses on the development and commercialization of precision medicines for various genetic diseases and cancers.
201-500 employees
H1B Sponsorship
BridgeBio has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (3)
2024 (5)
2023 (4)
2022 (4)
2021 (1)
2020 (2)
Funding
Current Stage
Public CompanyTotal Funding
$4.9BKey Investors
Blue OwlQatar Investment AuthorityKohlberg Kravis Roberts
2026-01-16Post Ipo Debt· $550M
2025-02-25Post Ipo Debt· $500M
2024-03-04Post Ipo Equity· $250M
Leadership Team
Justin To
CEO, Skeletal Dysplasias (QED Therapeutics)
Neil Kumar
CEO and Founder
Recent News
BioWorld Financial Watch
2026-01-17
Company data provided by crunchbase