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
Education
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