Process individual case safety reports (ICSRs) for clinical trials and post-marketing programs.
Ensure accurate data entry, coding, and query resolution in the Argus Safety Database.
Collaborate with cross-functional teams to meet regulatory reporting requirements and maintain compliance.
Precision Medicine Group is a global life sciences company specializing in precision medicine and drug development services. They employ thousands of professionals and emphasize a collaborative culture.
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 pharmacovigilance strategies and safety signal detection for Apogee's pipeline.
Collaborate with cross-functional teams to ensure high-quality safety data for regulatory submissions.
Provide medical oversight of safety data and contribute to benefit-risk assessments.
Apogee Therapeutics is a clinical-stage biotechnology company advancing novel biologics for inflammatory and immune-mediated diseases. Founded in 2022 and publicly traded, the company operates with a fast-paced culture grounded in C.O.R.E. values: Caring, Original, Resilient, and Egoless.
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.