Senior Medical Safety and Reporting Spec
The role provides day-to-day case monitoring, assessment and reporting of quality and adverse event complaint records involving Alcon manufactured products, and responds to complaint activities required to comply with local and international regulations, guidelines, and applicable directives. This role may be required to work in shifts.
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. • Mentor new hires in the team. • 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) • Provides suggestions to management on opportunities for continuous improvement, and actively engages as a team member in such projects. • Provide support in reconciliation activities and audit as required. • Evaluate and escalate potential safety issues to management.
Minimum requirements Minimum: Graduation in Science Desirable: Graduation in Optometry/ Pharmacy/ Biomedical Engineering / Registered nurse Minimum: English (written and spoken) Minimum: Healthcare professional with 2-5 years' of experience Desirable: 2-5 years' experience in Medical/Patient/Product safety preferably in Ophthalmology
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