Lead and manage all drug safety functions for investigational products across the organization.
Oversee pharmacovigilance activities, vendor management, and regulatory submissions.
Collaborate cross-functionally to ensure compliance and advance patient safety.
BridgeBio pioneered a 'moneyball for biotech' approach, pooling projects and early-stage research to reduce risk and accelerate innovation. The company focuses on rare diseases with small expert teams and a culture of curiosity and ethical AI use.
Manage safety contract service organizations (CSOs) to ensure ≥95% compliance with global safety regulations and corporate KPIs.
Oversee AE intake from global data sources and prepare assessments of safety data for internal leadership and regulatory authorities.
Maintain audit trail as inspection-ready at all times and direct participation in agency inspections (FDA, EMA, Health Canada, etc.).
BridgeBio Pharma pioneers a pooled risk model for biotech, advancing early-stage research to develop life-changing medicines for rare diseases. They are a multi-state employer with a culture of curiosity, experimentation, and high expectations for their team members.
Develops and directs global regulatory strategy to obtain and maintain product approvals across key regions.
Serves as primary regulatory contact for health authorities and leads cross-functional regulatory sub-teams.
Identifies regulatory risks and provides strategic guidance for product development and lifecycle management.
Rezolute is a late-stage rare disease biopharmaceutical company focused on developing transformative therapies for patients with severe metabolic and endocrine disorders. It is a publicly traded company driven by scientific innovation, collaboration, and integrity.
Lead life sciences customers in the rapid configuration and implementation of Vault Safety.
Define strategies, business processes, and implementation program(s) for deploying Vault Safety across an organization.
Provide subject matter expertise on Drug Safety and Pharmacovigilance for customers and project teams.
Veeva Systems helps life sciences companies bring therapies to patients faster via industry cloud. They are one of the fastest-growing SaaS companies, surpassing $3B in revenue, and committed to balancing the interests of customers, employees, society, and investors.