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Senior Director of Drug Safety - Remote

Posted 5 weeks ago
All others
Full Time
CA, USA
$255,000 - $345,000 USD/year

Overview

The Senior Director of Drug Safety will manage all aspects of drug safety functions related to postmarketing surveillance, ensuring compliance and strategic partnerships while collaborating with various departments.

In Short

  • Manage drug safety relationships with partners and vendors.
  • Oversee postmarket pharmacovigilance systems.
  • Develop assessments of global safety data.
  • Ensure compliance with safety data exchange agreements.
  • Act as a liaison for safety signal management.
  • Support safety review meetings with stakeholders.
  • Prepare reports for management and regulatory agencies.
  • Implement pharmacovigilance SOPs.
  • Collaborate with other BridgeBio affiliates on projects.
  • Travel as required.

Requirements

  • Bachelor’s degree in a health care discipline; advanced degree preferred.
  • 12+ years of drug safety and pharmacovigilance experience.
  • Experience with FDA and international regulatory authorities.
  • Management experience in drug safety or CSO.
  • Knowledge of GCP and FDA regulations.
  • Experience in clinical trial and post-marketing safety.
  • Strong communication and collaboration skills.
  • Ability to manage compliance deviations.
  • Experience with safety signal management systems.
  • Familiarity with safety databases and reporting tools.

Benefits

  • Patient Days to hear from individuals impacted by conditions.
  • A culture focused on patient-first values.
  • Decentralized model for decision-making.
  • Opportunities for career advancement.
  • Access to learning and development resources.
  • Market-competitive compensation and benefits package.
  • Flexible PTO.
  • Commitment to Diversity, Equity & Inclusion.
BridgeBio logo

BridgeBio

BridgeBio is a biopharmaceutical company dedicated to discovering, creating, testing, and delivering transformative medicines for patients suffering from genetic diseases and cancers with clear genetic drivers. Founded in 2015, BridgeBio bridges the gap between groundbreaking advancements in genetic science and the delivery of meaningful therapies. The company has developed a diverse portfolio of over 30 drug development programs across various therapeutic areas, including genetic dermatology, precision oncology, and rare diseases, with a commitment to scientific excellence and rapid execution. With offices in the U.S. and international locations, BridgeBio fosters a culture that prioritizes patient needs, encourages independent thinking, and values transparency.

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