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.