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Senior Director, Drug Safety and Pharmacovigilance

1 month ago
United States
Full-time
Lead
Operations Manager
Operations
Apply Now
bridgebiowp

bridgebiowp

bridgebiowp is a biotechnology firm focused on designing transformative medicines specifically for patients suffering from genetic diseases and cancers that have identifiable genetic drivers.

Pharmaceuticals
251-1K
Founded 2014
$2300M raised
View All Jobs 15

Description

  • Maintain post-market and clinical trial pharmacovigilance data systems for ICSR handling, periodic reporting, and inspection readiness.
  • Manage safety contract service organizations (CSOs) to achieve at least 95% compliance with clinical and post-market safety regulations, processes, PV agreements, and database management.
  • Oversee safety CSOs for post-market programs to support global safety systems and corporate goals.
  • Maintain adverse event intake from global data sources, including Organized Data Collection Systems.
  • Develop and prepare global safety data analyses for internal senior leadership and external partners or regulatory authorities.
  • Maintain audit trails and keep safety systems inspection ready at all times.
  • Partner with other BridgeBio affiliates on strategic input and assigned non-product or non-compound projects.
  • Support regulatory agency inspections and compliance activities as needed.
  • Manage change control, compliance deviations, and CAPAs related to safety systems.

Requirements

  • Bachelor’s degree in a health care discipline or equivalent required; advanced degree preferred.
  • At least 12 years of drug safety and pharmacovigilance experience, including post-market safety experience in biotechnology, pharmaceutical, or safety CSO settings.
  • At least 3 years of PV business management experience leading safety systems maintenance and regulatory agency inspections.
  • Experience in both clinical trial safety and post-marketing safety required.
  • Demonstrated self-direction and accountability, including during inspection activities.
  • Experience with regulatory submissions for PSUR, PBRER, and RMP; experience in the U.S., EU, Canada, Brazil, and Australia preferred.
  • Direct participation in agency inspections, including FDA, EMA, Health Canada, and others.
  • Experience managing change management, compliance deviations, and CAPAs.
  • Expertise with clinical trial and post-market safety databases such as Argus, ArisG, and/or Veeva Safety, plus Microsoft Office Suite (Word, Excel, PowerPoint, Project, Outlook).
  • Must be able and willing to travel.

Benefits

  • Salary range of $250,000 to $289,000 USD for California-based candidates.
  • Market-leading compensation with an annual performance bonus and company equity.
  • 401(k) with employer match.
  • Employee Stock Purchase Program (ESPP).
  • Pre-tax commuter benefits for transit and parking.
  • Referral bonus for hired candidates.
  • Subsidized lunch and parking on in-office days.
  • 100% employer-paid medical, dental, and vision premiums for employees and dependents.
  • Health Savings Account (HSA) with annual employer contributions and Flexible Spending Accounts (FSA).
  • Fertility and family-forming benefits.
  • Expanded mental health support, including therapy and coaching resources.
  • Hybrid work model with flexibility; U.S.-based remote role with quarterly or as-needed visits to the San Francisco office.
  • Flexible, take-what-you-need paid time off and company-paid holidays.
  • Comprehensive paid medical and parental leave.
  • Professional development and career pathing through LinkedIn Learning, LifeLabs, and BetterUp Coaching.

Interested in this position?

Apply directly on the company website

Apply Now

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