Sr. Principal, Patient Safety & Experience

About the role

The Senior Principal, Patient Safety and Experience at Alcon is responsible for evaluating safety signals from clinical trials and post-market surveillance data. This role ensures compliance with regulatory standards and communicates findings to internal teams and external regulatory bodies.

Responsibilities

• Perform medically based review of single adverse event cases and aggregate data involving assigned products.
• Review adverse event, clinical trial safety and post-market surveillance reports related to safety signals to identify and evaluate potential safety concerns.
• Collaborate with other associated groups to assess the clinical implications of safety signals.
• Provide safety input into clinical trials and regulatory deliverables including Investigator Brochures, clinical trial protocols, clinical study reports, clinical overviews, Clinical Evaluation Reports, and product registrations.
• Maintain the clinical safety of assigned products/projects, including adverse events, and patient impact from tech complaints from studies, literature and post-market surveillance.
• Identify safety signals based on review of solicited or unsolicited cases. Perform signal triage activities, evaluation, and presentation to Alcon safety boards, including preparatory activities.
• Support Business Development & Licensing (BD&L) activities, HA inspections/audits and project/product recalls, as assigned.
• Prepare and maintain Post Market Surveillance Plans, periodic safety updates, product labeling and related documents.
• Monitor the clinical safety of assigned products/projects, including adverse events, and patient impact from tech complaints from studies, literature and post-market surveillance.
• Author or provide safety input into the preparation and maintenance of Post Market Surveillance Plans, periodic safety updates, product labeling and related documents.
• Provide medically based responses to health authority inquiries on safety data and information.
• Communicate clinical findings and recommendations to stakeholders, leadership and safety boards.
• Maintain detailed and accurate records of clinical evaluations and regulatory communications.
• Ensure timely and thorough safety documentation that meets internal and external standards.
• Prepare Medical Safety presentations for Escalations and support analysis during Escalation meetings from the Medical Safety perspective, as assigned.

Requirements

The ideal candidate should have a Bachelor’s Degree or equivalent years of directly related experience, or a combination of education and experience. A Master’s degree or higher is preferred. Additionally, the candidate must have 7 years of relevant experience, preferably in an ophthalmic setting.

Qualifications

• Bachelor’s Degree or Equivalent years of directly related experience (or high school+15 yrs; Assoc.+11 yrs; M.S.+4 yrs; PhD+3 yrs)
• The ability to fluently read, write, understand and communicate in English
• M.D. Ophthalmologist or O.D.

Skills

Strong scientific and analytical skills, excellent communication and collaboration abilities, and the ability to manage multiple projects simultaneously are required.

Benefits

Alcon offers a comprehensive benefits package including health, life, retirement, flexible time off, and much more!

Pay

Competitive salary and benefits package.

Schedule

Full-time, on-site in Fort Worth, Texas.