Key Responsibilities:
- Case Processing:
- Process case files according to Standard Operating Procedures (SOP).
- Coordinate with affiliate offices to ensure the required dataset is received/requested.
- Re-assess data, ensure accurate product selection, and assign necessary event codes in the system.
- Complete initial and follow-up reporting assessments as information is received.
- 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 regulations.
- Perform and receive quality feedback on case management and coding.
- Adhere to all corporate compliance guidelines and programs.
- Knowledge Maintenance:
- Maintain working knowledge of Alcon Products for assigned therapeutic areas and corresponding documentation (Product Information, Directions for Use, Manuals, Promotional materials).
- Understand eye anatomy, common diseases, ophthalmic evaluation procedures, eye terminology, and abbreviations.
- Familiarize with safety databases and reporting tools.
- Complaint Processing:
- Process and review Surgical – Intraocular Lens (IOL) complaint records according to Alcon SOPs.
- Provide support in reconciliation activities and audits as required.
- Evaluate and escalate potential safety issues to management.
Key Performance Indicators (KPIs):
- Meets internal and external quality standards.
- Reviews and closes files within prescribed timelines.
- Creates high-quality regulatory reports for submission on or before assigned due dates.
Ideal Background:
- Education:
- Minimum: Graduation in Science.
- Desirable: Graduation in Optometry, Pharmacy, M. Pharm, B. Pharm, BDS, BAMS, BHMS, Biomedical Engineering, or Registered Nurse.
- Experience:
- Minimum: Healthcare professional with 1-2 years of experience.
- Desirable: Experience in Device Vigilance, Pharmacovigilance, Regulatory Submissions, Clinical Research, PVPI, or Medical Coding.
- Languages:
- Minimum: English (written and spoken).
Professional Competencies:
- Excellent listening and communication skills.
- Strong decision quality and negotiation skills.
- Ability to manage multiple tasks, prioritize work, and manage time effectively.
- Knowledge of national and international medical device regulations and regulatory guidelines.
- Basic knowledge of MS Office.
