Alcon, a global leader in eye care, is seeking an Associate I – Safety Informatics to join its team in Bangalore. This role involves analyzing post-market surveillance data, detecting safety signals, and ensuring compliance with global regulatory standards.
Key Responsibilities:
- Analyze Post-Market Surveillance Data – Evaluate adverse event trends from global sources like MAUDE, FAERS, EUDAMED, and internal complaint databases.
- Data Management – Organize and manage complex datasets using advanced database systems.
- Reporting & Visualization – Develop dashboards, visualizations, and summary reports for stakeholders and regulatory submissions.
- Cross-Functional Collaboration – Work with safety physicians, data scientists, and regulatory teams to assess post-market safety data.
- Regulatory Compliance – Stay updated on FDA, MDR, ISO 14971, and other regulatory guidelines.
- Process Improvement – Contribute to enhancing safety signal detection methodologies.
- Data Privacy & Ethics – Ensure compliance with data privacy and ethical regulations.
🎓 Educational Qualifications:
- Bachelor’s or Master’s degree in a relevant field such as:
- Life Sciences (Pharmacy, Biotechnology, Microbiology, etc.)
- Biomedical Engineering
- Public Health / Epidemiology
- Data Science / Biostatistics
- Health Informatics or a related discipline
🧠Preferred Skills and Experience:
- Knowledge of safety data sources: Familiarity with MAUDE, FAERS, EUDAMED, and internal complaint databases.
- Data management skills:
- Experience with databases, SQL, Excel, or data visualization tools like Tableau, Power BI, Spotfire.
- Strong analytical and statistical skills.
- Regulatory understanding:
- Awareness of FDA regulations, European MDR, ISO 14971 (risk management for medical devices).
- Cross-functional collaboration:
- Experience working with safety physicians, regulatory affairs, data scientists, or quality teams.
- Reporting and communication:
- Ability to create dashboards, safety reports, and summaries for internal/external stakeholders.
- Tools and methodologies:
- Familiarity with safety signal detection tools or pharmacovigilance software (e.g., Argus, Empirica).
About Alcon
Alcon is the global leader in eye care, dedicated to helping people see brilliantly. With a legacy of innovation, Alcon develops cutting-edge surgical equipment, contact lenses, and pharmaceutical solutions to improve vision worldwide.
Why Join Alcon?
✔ Global Impact – Work on products that enhance vision for millions.
✔ Innovative Environment – Be part of a team that drives medical advancements.
✔ Diverse & Inclusive Culture – Alcon is an Equal Opportunity Employer, fostering diversity and inclusion.
How to Apply
