Develop safety management plans and oversee serious adverse event case management from intake to regulatory reporting.
Perform intake, triage, data entry, medical coding, and narrative composition for individual case safety reports.
Provide safety training, review standard operating procedures, and assist clients with safety-related reviews.
Precision Medicine Group is a global contract research organization specializing in clinical research and drug development services. The company fosters a collaborative culture and offers competitive benefits to support employee growth.
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.
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.