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Alcon Patient Safety Monitor job vacancy | Pharmacy/M. Pharm/B. Pharm /BDS/BAMS/BHMS/ Biomedical Engineering / Registered Nurse
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.
Major Accountabilities (Describe the main results of the job to be achieved)
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.
Key Performance Indicators (Indicate how performance will be measured: indicators, activities…)
KPIs will be outlined in detail in the goal sheet, and will largely be around below parameters:
Meets internal and external quality standards
Review and close files within prescribed timelines
Creates high quality regulatory reports for submission on or before assigned due dates
Ideal Background (State the minimum and desirable education and experience level)
Education
Minimum: Graduation in Science
Desirable: Graduation in Optometry/ Pharmacy/M. Pharm/B. Pharm /BDS/BAMS/BHMS/ Biomedical Engineering / Registered Nurse
Experience requirement:
Minimum: Healthcare professional with 1-2 years of experience
Desirable: Experience in Device Vigilance / Pharmacovigilance / Regulatory Submissions / Clinical Research / PVPI/ Medical Coding
Languages:
Minimum: English (written and spoken)
Specific Professional Competencies: Indicate any other soft/technical/professional knowledge and skills requirements
Excellent listening ability and communication skills
Excellent decision quality and negotiation skills
Ability to manage multiple tasks, attention to detail, prioritize work and manage time well
Knowledge and understanding of national and international medical device regulations and regulatory guidelines
Knowledge of medical aspects of medical device safety, medical device vigilance in pre- and post-marketing safety practice
Basic knowledge of MS Office
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