Alcon, we are committed to helping people see better. We believe patients should have access to quality eye care regardless of their economic circumstances; however, barriers to good eye health exist for patients in both developed and emerging markets. Alcon develops and manufactures innovative devices to serve the full life cycle of eye care needs. Its surgical group is one of the largest makers of equipment used for cataract removal and laser vision correction.
Post : Senior Patient Safety Specialist
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.
• 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.
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
• 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
Minimum: Graduation in Science
Desirable: Graduation in Optometry/ Pharmacy/ Biomedical Engineering / Registered nurse
Minimum: Healthcare professional with 2-5 years’ of experience
Desirable: 2-5 years’ experience in Medical/Patient/Product safety preferably in Ophthalmology
Languages : English (written and spoken)
Experience : 2-5 years
Qualification : BSc, B.Pharm
Location : Bangalore, Karnataka
Industry Type : Pharma/ Healthcare/ Clinical research
End Date : 30th December, 2020
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