Director, Drug Safety & Pharmacovigilance

Mavericks Wanted

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Eidos Therapeutics, an affiliate within BridgeBio Pharma, is a commercial-stage biopharmaceutical company focused on Transthyretin Amyloid Cardiomyopathy (ATTR-CM).

• Director of Drug Safety will be responsible for managing all aspects of the drug safety functions related to US and assigned postmarketing data review and reporting. 
   

• Manage the drug safety contract service organizations (CSOs) for postmarket pharmacovigilance with
  >=95% compliance with periodic reporting, signal management, and global risk management plans
  and, manage on-time and scientifically sound local safety report preparation, and ensure the drug safety functions of the CSOs meet corporate goals and key performance indicators 
   

• Develop and prepare assessments of global safety data,
  signal management
  , and benefits/risks for internal senior management as well as external partner or regulatory authorities
   

• Accountable for global periodic safety review and
  signal management meetings
  , and relationships with all internal and external stakeholders, and
  maintain audit trail as inspection ready
  at all times
   

• Accountable for maintenance and inspection readiness of the quality management system for signal management (GVP Module IX.B.5) and PBRER preparation 
   

• Leads data collection for signal examination and assessment within timelines
   

• Accountable for ad hoc safety review meetings, including all internal and external stakeholders, with 100% compliance with signal evaluation timelines, and maintain audit trail as inspection ready at all times
   

• Manages the
  authoring of aggregate reports including PBRER
  , and
  other local safety reports
  as required
   

• Manages the
  authoring and collaboration with partner for global risk management plans
   

• Manages the PV agreements and compliance of all assigned
  local distribution organizations
  and for compliance tracking for all safety submissions across all drug safety functions of the
  local distribution organizations,
  maintain audit trail as inspection ready at all times
   

• Oversee the
  creation of periodic report and signal management reports, analysis, and presentation
  of safety data from the safety database, and maintain audit trail as inspection ready at all times
   

• Manages ongoing reconciliation of incoming safety information and the safety databases
   

• Develops and prepares reports for company management as well as external regulatory agencies
   

• Ensure compliance with standard operating procedures and clinical trial and post-market global drug safety regulations, including to the FDA, EMA, MHRA, and all assigned international RAs
   

• Implement pharmacovigilance SOPs and ensure the uniform and timely processing of adverse event data in all assigned development and post-marketing programs
   

• When requested, work with other BridgeBio Affiliates to provide strategic input and work on assigned non-product/compound-related projects
   

This a U.S-based remote role that will require quarterly, or as needed visits to our San Francisco Office.