The Patient Safety Monitor is responsible for daily case monitoring, assessment, and reporting of quality and adverse event complaint records for Alcon manufactured products. The role ensures compliance with local and international regulations and guidelines, and may require shift work.
Major Accountabilities
- Case Processing:
- Process case files according to Standard Operating Procedures (SOP).
- Coordinate with affiliate offices to ensure receipt of required datasets.
- Re-assess data for accurate product selection and assign appropriate event codes.
- Complete initial and follow-up reporting assessments as new information is received.
- Respond to Manufacturing Quality Assurance (QA) requests and Health Authority inquiries.
- Initiate required quality investigation records.
- Schedule regulatory reports (expedited and periodic) based on local and international regulations.
- Perform and receive feedback on case management and coding.
- Adhere to all corporate compliance guidelines and programs.
- Knowledge Maintenance:
- Maintain knowledge of Alcon products, eye anatomy, common diseases, ophthalmic procedures, and safety databases.
- Process and review complaint records for Surgical – Intra Ocular Lens (IOL) in accordance with SOPs.
- Support reconciliation activities and audits as needed.
- Evaluate and escalate potential safety issues to management.
Key Performance Indicators
- Meeting internal and external quality standards.
- Timely review and closure of files.
- High-quality regulatory report submissions on or before due dates.
Ideal Background
Education:
- Minimum: Graduation in Science.
- Desirable: Graduation in Optometry, Pharmacy, M.Pharm, B.Pharm, BDS, BAMS, BHMS, Biomedical Engineering, or as a Registered Nurse.
Experience:
- Minimum: 1-2 years as a healthcare professional.
- Desirable: Experience in Device Vigilance, Pharmacovigilance, Regulatory Submissions, Clinical Research, PVPI, or Medical Coding.