Associate I, Patient Safety

Job Purpose (State in one sentence the overall objective of the job)

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.

Role Dimensions:
Number of associates:
None

Financial responsibility:
None

Impact on the organization:
Low

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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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.