Das ist der Job
Accountable for maintaining AE intake from global data sources including Organized Data Collection Systems.
Darum lohnt es sich
Responsibilities The primary responsibilities are to manage safety contract service organizations (CSOs) with ≥95% compliance with clinical and postmarket safety regulations (including FDA, EMA, MHRA, and all assigned international RAs), processes, PV agreements, and database management.
Senior Director, Drug Safety and Pharmacovigilance Remote - USA Salary: $250,000 – $289,000 USD What You’ll Do Accountable for maintenance of post market and clinical trial pharmacovigilance data systems for ICSR handling, periodic reporting, and safety inspection readiness.
Oversee safety CSOs for postmarket programs to achieve global safety systems to meet corporate goals and key performance indicators. Develop and prepare assessments of global safety data analyses for internal senior leadership as well as external partner or regulatory authorities. Maintain audit trail as inspection ready at all times.
When requested, work with other BridgeBio Affiliates to provide strategic input and work on assigned non-product/compound-related projects. Where You’ll Work U.S.-based remote role that requires quarterly or as needed visits to our San Francisco Office.
Who You Are Bachelor’s degree in a health care discipline or equivalent is required, and an advanced degree is preferred. Requires at least 12 years of drug safety and pharmacovigilance experience (post-market safety experience in the b
