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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