Novartis
Medical Safety and Reporting Specialist , Graduation in Optometry/ Pharmacy/
Biomedical Engineering / Registered nurse
Job
Description
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.
•
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.
Minimum
requirements
Minimum:
Graduation in Science Desirable: Graduation in Optometry/ Pharmacy/ Biomedical
Engineering / Registered nurse Minimum: English (written and spoken) Minimum:
Healthcare professional with 1-2 years’ of experience Desirable: 1-2 years’
experience in Medical/Patient/Product safety preferably in Ophthalmology
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