Sr Principal, Patient Safety & Experience at Alcon

Fort Worth, Texas, United States

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Not SpecifiedCompensation

Senior (5 to 8 years), Expert & Leadership (9+ years)Experience Level

Full TimeJob Type

UnknownVisa

Healthcare, Pharmaceuticals, Eye Care, Medical DevicesIndustries

Requirements

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
7 Years of Relevant Experience
Preferred: M.D Ophthalmologist or O.D

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
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
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 BD&L activities, HA inspections/audits and project/product recalls, as assigned
Preparation and maintenance of Health Hazard Assessments and responses to regulatory authorities, HCPs, local affiliates and Legal on Safety-related issues
Assess the clinical significance of reported adverse events leading to safety signals/observations and their relevance and potential impact on patient outcomes
Provide clinical input to help guide risk management safety decisions
Ensure all clinical evaluations meet regulatory standards (e.g., US FDA, EU MDR, etc) and prepare clinical sections of regulatory submissions
Provide medically based responses to health authority inquiries on safety data and information
Communicate clinical findings and recommendations to stakeholders, leadership and safety boards
Align with Medical Writers and regulatory stakeholders on safety documentation and communication
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
Provide safety surveillance throughout a product's lifecycle through safety trending, signal detection, and risk management assessments
Evaluate safety signals from clinical trials and post-market surveillance data
Assess the clinical significance of safety data, ensuring compliance with regulatory standards, and communicating findings to internal teams and external regulatory bodies to help maintain patient safety

Skills

Key technologies and capabilities for this role

safety signal detectionadverse event reviewpost-market surveillancerisk managementsignal evaluationregulatory complianceclinical trial safetysafety trendingInvestigator Brochuresclinical study reportsClinical Evaluation Reports

Questions & Answers

Common questions about this position

Is this role remote or on-site?

This role is on-site in the Fort Worth, Texas location.

What are the key responsibilities of this position?

The role involves evaluating safety signals from clinical trials and post-market surveillance, assessing clinical significance of safety data, ensuring regulatory compliance, and providing safety input into clinical trials and regulatory deliverables.

What skills or experience are required for this role?

The position requires expertise in medically based review of adverse events, safety signal detection and evaluation, regulatory compliance (e.g., US FDA, EU MDR), and collaboration with cross-functional teams on safety assessments.

What is the company culture like at Alcon?

Alcon fosters an inclusive culture, innovates boldly, champions progress, acts with speed, and recognizes employees for their commitment and contributions while making an impact in eye care.

What makes a strong candidate for this position?

Strong candidates will have medical or clinical expertise in patient safety, experience with adverse event review, signal detection, regulatory compliance, and the ability to collaborate across teams on safety surveillance and risk management.

Alcon

Specializes in eye care products and solutions

About Alcon

Alcon specializes in eye care products and vision solutions aimed at improving people's quality of life through better vision. Their product offerings include solutions for cataract surgery, retinal health, and contact lenses. Alcon's products work by utilizing advanced technology and research to provide effective treatments and aids for various eye conditions. What sets Alcon apart from its competitors is its strong emphasis on research and development, ensuring that they remain leaders in the eye care industry. The company's goal is to enhance vision and overall quality of life for individuals while promoting a diverse and inclusive workplace.

Geneva, SwitzerlandHeadquarters

1945Year Founded

IPOCompany Stage

Social Impact, HealthcareIndustries

10,001+Employees

Benefits

Medical, dental, & vision coverage

HSA Medical Plan

PTO

Paid Parental leave

401k

Retirement Plan Company Contribution

Low payroll deductions

Tuition Reimbursement Program

Annual Bonus

Free Family Contact Lens Program

12 Company Paid Holidays

Risks

FDA recall of contact lenses may harm Alcon's reputation and financial standing.

Antitrust case denial could lead to legal challenges and financial penalties.

Innovative competitors like Signal12 threaten Alcon's market share in eye care.

Differentiation

Alcon leads in eye care with a broad product portfolio and global reach.

The company invests heavily in R&D, ensuring cutting-edge vision solutions.

Alcon's commitment to diversity and inclusion strengthens its corporate culture.

Upsides

Acquisition of BELKIN Vision enhances Alcon's glaucoma treatment options with DSLT technology.

Orbis Flying Eye Hospital project boosts Alcon's global presence and eye care standards.

Recognition as a top employer in Singapore attracts and retains top talent.

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