The Associate II, Patient Safety & Experience (non-MD) at Alcon is responsible for day-to-day case monitoring, assessment, and reporting of quality and adverse event complaints related to Alcon-manufactured products. The role ensures compliance with local and international regulations and may require working in shifts.
Key Responsibilities (Major Accountabilities)
Case Processing:
- Process case files following Standard Operating Procedures (SOPs).
- Collaborate with affiliate offices to gather required datasets.
- Reassess data, ensure accurate product selection, and assign appropriate event codes.
- Complete initial and follow-up reporting based on received information (questionnaires, investigation findings, etc.).
- Respond to Manufacturing QA requests and Health Authority inquiries.
- Initiate quality investigation records and schedule expedited/periodic regulatory reports.
- Maintain compliance with corporate guidelines and programs.
Knowledge & Skills Required:
- Understanding of Alcon products (therapeutic areas, product documentation).
- Knowledge of eye anatomy, common diseases, ophthalmic procedures, and terminology.
- Experience with safety databases and reporting tools.
- Handling Surgical – Intra Ocular Lens (IOL) complaints as per SOPs.
- Supporting audit and reconciliation activities.
- Escalating potential safety issues to management.
Key Performance Indicators (KPIs)
- Meeting internal and external quality standards.
- Timely review and closure of case files.
- High-quality regulatory report submissions within deadlines.
Eligibility Criteria
Education:
- Minimum:Â Graduation in Science
- Preferred:Â Optometry, Pharm-D, M.Pharm, BDS, BAMS, BHMS
Experience:
- Minimum:
- Healthcare professionals with 0-2 years of experience.
- Optometry graduates with 0-1 year of experience.
- Preferred:
- 0-2 years in Device Vigilance, Pharmacovigilance, Regulatory Submissions, Clinical Research, PVPI, or Medical Coding.
Languages:
- English (written & spoken)
Professional Competencies:
- Strong communication & negotiation skills.
- Ability to manage multiple tasks, prioritize, and meet deadlines.
- Knowledge of medical device regulations (national & international).
- Familiarity with medical device safety & vigilance practices.
- Basic MS Office proficiency.
About Alcon
Alcon is a global leader in eye care, dedicated to helping people see brilliantly. With a focus on innovative surgical, vision care, and pharmaceutical products, Alcon aims to enhance quality of life through cutting-edge eye health solutions.
