BridgeBio · 7 hours ago
Sr. Medical Director, Drug Safety and Pharmacovigilance
United States
Full-time
Remote
Senior Level, Lead/Staff
$325K/yr - $370K/yr
12+ years expBridgeBio is a biopharmaceutical company focused on developing life-changing medicines for rare diseases. The Sr. Medical Director, Drug Safety and Pharmacovigilance, is responsible for overseeing the risk management and safety strategy of assigned products, ensuring compliance and collaboration with regulatory authorities and clinical teams.
BiotechnologyHealth CareLife ScienceMedicalPharmaceutical
Responsibilities
Support the clinical development team in the review of key documents, including protocol and ICFs
Manage the drug safety contract service organizations (CROs) for clinical programs to ensure compliance with expedited reporting, manage on-time and scientifically sound DSUR preparation, and ensure the drug safety functions of the CROs meet corporate goals and key performance indicators
Assist in the medical review of adverse event reports; manage preparation and submission of drug safety expedited reporting in compliance with regulations, when necessary
Develop and prepare assessments of safety data, safety signals, and benefit/risk for internal senior management as well as external partner or regulatory authorities
Assist in the authoring of aggregate reports
Qualification
Required
Medical Degree
Requires at least 12 years of drug safety and pharmacovigilance experience (clinical trials safety experience in the biotechnology, pharmaceutical, drug safety contract service organization (CSO)) with at least two years of oversight management experience (line management or CSO management)
Extensive experience with all aspects of safety signal evaluation, including review and analysis of data, collaboration with cross-functional team members and senior management, authoring of required regulatory correspondence, and safety label updates
Experience in both clinical development and post-marketing safety
Experience with Regulatory submissions for NDAs, EU MAAs, and other countries' Regulatory reviews
Demonstrated ability to successfully manage a drug safety team or drug safety CRO for a clinical development program with responsibilities for expedited reporting, on-time DSUR preparation
Experience in drug safety audits and agency inspections
Intimate knowledge of GCP and strong working knowledge of FDA, Good Clinical Practices, and ICH regulations and guidelines
Proven ability to collaborate successfully with clinical trial teams, including data management, clinical sciences, medical monitors, clinical operations, biostats, regulatory, medical writing, and QA
Experience in managing all clinical safety aspects of product quality defect investigations and assessments
Management of compliance deviations and formulation of CAPAs
Familiar with clinical trial safety database use and CIOMS II and DSUR reporting generation (Argus, ArisG, or VeevaSafety) and Microsoft Office Suite required (Word, Excel, PowerPoint, Project, Outlook)
Must be able and willing to travel periodically for face-to-face engagements with regulatory authorities, and occasional on-site meetings (if based remotely)
Benefits
401K with 100% employer match on first 3% & 50% on the next 2%
Employee stock purchase program
Pre-tax commuter benefits
Referral program with $2,500 award for hired referrals
Comprehensive health care with 100% premiums covered - no cost to you and dependents
Mental health support via Spring Health (6 therapy sessions & 6 coaching sessions)
Hybrid work model - employees have the autonomy in where and how they do their work
Unlimited flexible paid time off - take the time that you need
Paid parental leave - 4 months for birthing parents & 2 months for non-birthing parents
Flex spending accounts & company-provided group term life & disability
Subsidized lunch via Forkable on days worked from our office
People are part of our growth and success story - from discovery to active drug trials and FDA pipelines, there are endless opportunities for skill development and internal mobility
We provide career pathing through regular feedback, continuous education and professional development programs via LinkedIn Learning, LifeLabs, Spring Health & BetterUp Coaching
We celebrate strong performance with financial rewards, peer-to-peer recognition, and growth 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
$4.35BKey Investors
Blue OwlQatar Investment AuthorityKohlberg Kravis Roberts
2025-02-25Post Ipo Debt· $500M
2024-03-04Post Ipo Equity· $250M
2024-01-18Post Ipo Debt· $1.25B
Leadership Team
Justin To
CEO, Skeletal Dysplasias (QED Therapeutics)
Neil Kumar
CEO and Founder
Recent News
2026-01-05
2025-12-24
Company data provided by crunchbase