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 portfolio. Based in Fort Worth, Texas, you will oversee safety signal evaluation from clinical trials through post‑market surveillance, 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, evaluate, and triage safety signals from clinical trial, post‑market, and literature sources.
• Collaborate with cross‑functional teams to assess clinical implications and guide risk‑management decisions.
• Provide safety input for clinical trial documents, regulatory submissions, and product labeling.
• Maintain and update Post‑Market Surveillance Plans, periodic safety reports, and health hazard assessments.
• Support business development, health authority inspections, audits, and product recalls as required.

Required profile

• Advanced degree in a health‑related discipline (e.g., PharmD, MD, MSc in Clinical Safety).
• Extensive experience in clinical safety evaluation, signal detection, and risk management within the medical device or pharmaceutical industry.
• Deep knowledge of US FDA, EU MDR, and other global regulatory requirements.
• Proven ability to communicate complex safety findings to internal stakeholders and regulatory authorities.

Required skills

• Regulatory compliance expertise (FDA, EU MDR, etc.).
• Signal detection and risk‑management methodologies.
• Clinical safety assessment and adverse‑event analysis.