Senior Principal – Patient Safety & Experience

About the role

Alcon is seeking a Senior Principal to lead patient safety and experience initiatives for its eye‑care products. Based on‑site in Fort Worth, Texas, you will evaluate safety signals from clinical trials and post‑market data, ensuring regulatory compliance and protecting patient outcomes.

Key responsibilities

• Perform medically based reviews of individual adverse events and aggregate safety data for assigned products.
• Identify, assess, and triage safety signals from clinical trials, post‑market surveillance, literature and tech complaints.
• Collaborate with cross‑functional teams to evaluate clinical implications and provide safety input for trial protocols, investigator brochures, clinical study reports, and product registrations.
• Develop and maintain Post‑Market Surveillance Plans, periodic safety updates, product labeling, and health hazard assessments.
• Support business development, HA inspections/audits, product recalls, and respond to regulatory authority inquiries.
• Ensure all clinical evaluations meet FDA, EU MDR and other regulatory standards.

Required profile

• Extensive experience in clinical safety monitoring, signal detection and risk management within the medical device or pharmaceutical sector.
• Strong knowledge of regulatory requirements (US FDA, EU MDR, etc.) and post‑market surveillance processes.
• Proven ability to communicate complex safety findings to internal stakeholders and external authorities.

Required skills

• Regulatory compliance (FDA, EU MDR)
• Signal detection and triage
• Risk management assessment
• Clinical safety monitoring