Associate I, Patient Safety & Experience (non-MD)

Case Processing:

• Process case files according to Standard Operating Procedures (SOP).
• Work with affiliate offices to ensure required dataset has been received/requested.
• Re-assess the data, ensure accurate product selection and assign required event code(s) in the system.
• Complete initial and follow-up reporting assessments as information is received (initial report, follow-up questionnaires, phone calls, investigation findings).
• Respond to Manufacturing Quality Assurance (QA) requests and Health Authority inquiries
• Launch required quality investigation records.
• Schedule expedited and periodic regulatory reports based on local and international reporting regulations.
• Perform and receive quality feedback on case management and coding.
• Adherence to all corporate compliance guidelines & corporate programs .
• Maintains a working knowledge of the following:
• Alcon Products for assigned therapeutic areas and corresponding documentation (Product Information, Directions for Use, Manuals, Promotional materials)
• Eye anatomy
• Common diseases
• Ophthalmic evaluation procedures
• Eye terminology and abbreviations
• Safety database(s) and reporting tools
• Process and review Surgical – Intra Ocular Lens (IOL) complaint records in accordance with Alcon Standard Operating Procedures (SOPs)
• Provide support in reconciliation activities and audit as required.
• Evaluate and escalate potential safety issues to management.
  
  

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