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Alcon looking for Patient Safety Monitor


Clinical courses

Alcon looking for Patient Safety Monitor

Alcon is the global leader in eye care, dedicated to helping people see brilliantly. With an over 75-year heritage, we are the largest eye care device company in the world, with complementary businesses in Surgical and Vision Care. Being a truly global company, we work in 60 countries and serve patients in more than 140 countries. We have a long history of industry firsts, and each year we commit a substantial amount in Research and Development to meet customer needs and patient demands.

Post : Patient Safety Monitor

Job Description
• 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.
• 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

Candidate Profile
Minimum:  Graduation in Science
Desirable: Graduation in Optometry / Pharmacy / M.Pharm / B.Pharm / BDS / BAMS / BHMS / Biomedical Engineering / Registered Nurse
Minimum: Healthcare professional with 1-2 years of experience
Desirable: Experience in Device Vigilance / Pharmacovigilance / Regulatory Submissions / Clinical Research / PVPI/ Medical Coding

Additional Information
Experience : 1-2 years
Qualification : Graduation in Optometry/ Pharmacy/M. Pharm/B. Pharm
Location : Bangalore
Industry Type : Pharma/ Healthcare/ Clinical research
End Date : 15th november 2023

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