Principal Safety Scientist
•Performs device safety activities for assigned Novartis projects or products, including identification and comprehensive assessment of safety signals from all sources (clinical through post-approval lifecycle management and externally).
- Performs single case medical review in the safety database or line listings. Medical review will be performed by clinically/medically qualified associates.
- Monitors the clinical safety of assigned products/projects, including literature review, adverse events, patient impact from technical complaints, and signal detection.
- Provides safety input into clinical and regulatory deliverables, including Investigator’s Brochures, study protocols, reports, and clinical submission documents, as needed.
- Identifies safety signals based on the review of solicited or unsolicited single cases. Performs signal triage activities, evaluation, and presentation to Novartis Boards including preparatory activities.
- Authors or provides safety input to the Core Data Sheets and related documents.
- Contributes to the safety profiling and risk management documents.
- Provides guidance for coding, causality assessment, and determination of anticipated vs. unanticipated adverse event reports.
Alcon is an Equal Opportunity Employer and participates in E-Verify. As part of the Novartis Group of Companies, Alcon takes pride in maintaining a diverse environment and our policies are not to discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status. Alcon is also committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please send an e-mail to [email protected] and let us know the nature of your request and your contact information EEO Statement The Novartis Group of Companies are Equal Opportunity Employers and take pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status. Minimum requirements •Master of Science or health-related discipline is required. Fluent in English.
- At least 3 years of industry experience in product development, including 2 years in safety at an operational or medical position.
- Clinical knowledge of ocular anatomy and ophthalmic procedures.
- Proven ability to analyze, interpret, and discuss safety information.
- Good written and verbal communication.
- Experience in product development, clinical trial methodology, regulatory requirements, scientific methodology, statistics and writing of publications.
- Experience in preparing or contributing to preparation of clinical safety assessments and regulatory reports/ submissions involving safety information.
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