Associate I, Patient Safety and Experience

Alcon; Bengaluru; Presencial; INR 600 000 - 800 000; Tempo integral

Resumo da oferta

Alcon in Bengaluru, India seeks a QA professional to manage day-to-day case monitoring, assessment, and reporting of quality and adverse event records for Alcon products, ensuring compliance with local and international regulations. The role may require shift work and involves processing case files per SOP, coordinating with affiliate offices, and performing initial and follow-up reporting assessments.

You will support QA requests, regulatory inquiries, and routine regulatory reporting, while

Responsabilidades

• 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.
• Adherence to all corporate compliance guidelines & corporate programs.

Ferramentas

Safety databases

Descrição da oferta de emprego

• 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.


• 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)


• undefined


• Provide support in reconciliation activities and audit as required.


• Evaluate and esc

Alcon is an Equal Opportunity Employer and takes pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, gender identity, marital status, disability, or any other reason.