Medical Reviewer Ags

hace 6 meses

Ciudad de México Alcon A tiempo completo

At Alcon, we are driven by the meaningful work we do to help people see brilliantly. We innovate boldly, champion progress, and act with speed as the global leader in eye care. Here, you’ll be recognized for your commitment and contributions and see your career like never before. Together, we go above and beyond to make an impact in the lives of our patients and customers. We foster an inclusive culture and are looking for diverse, talented people to join Alcon.

As a Medical Reviewer, supporting Product Safety in our Mexico City office, you will be trusted to 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).

In this role, a typical day will include:
- 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.

WHAT YOU'LL BRING TO ALCON:
- Bachelor’s Degree- Board-certified ophthalmologist- The ability to fluently read, write, understand, and communicate in English- 1-3 years of experience- Travel Requirements: Up to 10%- Relocation assistance: No- Sponsorship available: No- A resourceful and consultative mentality- Team player- High level of emotional intelligence

HOW YOU CAN THRIVE AT ALCON:
- 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 SKILLS:
- Clinical experience post-doctoral- Medical device and/or pharmaceutical experience in product development, including 2 years in a medical or safety operations position- 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

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