Medical Reviewer
2 days ago
Job Purpose:
- Perform Medical Safety activities for assigned Alcon projects or products, supporting the identification and comprehensive assessment of safety signals from all sources (clinical development through post-approval lifecycle management and externally).
JOB FUNCTIONS
Essential Functions
- Duties are listed in order of greatest importance. Other responsibilities may be assigned._
Perform medical review of single cases and/or aggregate data involving the assigned product(s). Provide safety input to the clinical and regulatory deliverables, including Investigator's Brochures, study protocols, study reports, clinical overviews, and product registrations. Monitor the clinical safety of assigned products/projects, including adverse events and patient impact from technical complaints from studies, literature, and post-market surveillance. Compile, analyze, and interpret clinical and scientific data from multiple sources; summarize safety trends with supervisory guidance. Prepare literature summaries on special topics to characterize product safety profile and support risk management documents. Support the preparation and maintenance of post-market surveillance plans, periodic safety updates, product labelling and related documents. Support the preparation of health hazard assessments and responses to inquiries from health care authorities, health care professionals, or local affiliates. Support business development and licensing activities, health authority inspections/audits, and market action activities.
QUALIFICATIONS
Minimum Education
- Board-certified medical physician required, or other clinically-qualified professional considered based on therapeutic area experience
- Board-certified ophthalmologist (MD or equivalent) preferred
Preferred Education
- Additional advanced degree in scientific research
Minimum Work Experience
- 3 years of clinical experience post-doctoral
- 3 years of medical device and/or pharmaceutical experience in product development, including 2 years in a medical or safety operations position
Knowledge, Skills and Abilities
- Strong interpersonal, communication (written and verbal), and presentation skills
- Strong organizational and project management skills with proven successes in matrix setting
- Works effectively with other line functions in an international setting
- Demonstrates attention to detail, strategic thinking, and problem solving skills
- Experience with (safety or others) issue management
- Self-motivated, ability to work under pressure, demonstrating initiative and flexibility
- High learning agility, ability to work independently and meet targeted timelines in a team-centric environment
- Prior experience in scientific and technical writing in clinical research or regulated work environment
Preferred:
- User experience of company portfolio or similar products in clinical setting
- Knowledge of applicable industry standards and regulations, e.g., EU MDR, ICH, GCP, GVP
Alcon is an Equal Opportunity Employer and takes pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, gender identity, marital status, disability, or any other reason.
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