Director, Drug Safety & Pharmacovigilance

OpenKrill; United States; Hybride; USD 280 000 - 311 000; Plein temps

Avantages offerts par ce poste

Market-competitive compensation

Equity grant opportunities

Unlimited PTO

Company-wide shutdowns

Professional development opportunities

Remote-friendly with in-person work

Résumé du poste

Spyre Therapeutics is a clinical-stage biotechnology company focused on developing next-generation immunology therapies. The Director, Drug Safety Physician, will lead ICSRs review, DSUR and safety signal management, and provide medical safety input to trial documents, reporting to Sr VP, Drug Safety and Pharmacovigilance.

The role emphasizes global PV compliance, cross-functional leadership, and ongoing safety strategy development in a dynamic environment.

Qualifications

• MD with 6+ years of related Clinical Development Drug Safety/Medical Review experience
• Degree in epidemiology preferred or working knowledge in epidemiology/pharmacoepidemiology
• Experience with safety surveillance and signal detection activities
• Knowledge of global pharmacovigilance regulations (EMA, FDA)

Responsabilités

• Triage and medical review of ICSRs and oversight of AOSEs for expedited safety reporting
• Lead cross-functional medical review discussions of ICSRs
• Prepare/review DSURs and safety sections of clinical trial documents and regulatory filings
• Lead literature reviews and summaries to support aggregate safety analyses
• Contribute to safety data reviews, surveillance, and signal management
• Coordinate safety meetings (SMT/SRT) and safety surveillance initiatives
• Assist in PV process improvements and SOP/document development
• Provide input into safety risk language and risk management plans
• Collaborate with Medical Review Lead on developing unified medical-review approaches

Connaissances

Analytical skills

Communication skills

Problem-solving

Leadership

Formation

MD

Epidemiology degree preferred

Outils

Argus global safety database

Description du poste

Spyre Therapeutics is a clinical-stage biotechnology company focused on developing next-generation immunology therapies. The Director, Drug Safety Physician, will lead ICSRs review, DSUR and safety signal management, and provide medical safety input to trial documents, reporting to Sr VP, Drug Safety and Pharmacovigilance.

The role emphasizes global PV compliance, cross-functional leadership, and ongoing safety strategy development in a dynamic environment.