Medical Device Complaint Handling Specialist
•Responsible for day-to-day case management of quality technical and adverse event com-plaint records, including intake, follow up, triage and system entry, involving Alcon device products.
- Complaint handling accountabilities reflect activities required to comply with local and international regulations, guidelines, and applicable directives.
- Receive initial complaint from any source (ECPs, patients, internal Alcon personnel) and assure all information/data is accurately captured at point of contact
- Maintain an understanding of information/data required to be collected for technical and AE complaints to assure compliance with regulations and directives.
- Manage technical and adverse event complaint records for assigned area(s) using designated safety system(s)
- Review potential complaint data received via safety system(s) and other methods, as required
- Is cognizant of, and works efficiently within applicable time zones
- Performs intake / follow up / data entry activities and attaches corresponding source documents in a timely manner per requirements and directives.
- Performs data entry for affiliates without access to safety database(s).
- Triage call from all sources for quality technical complaint, Adverse Event, request for refund, request for replacement product and request for credit.
- Reviews data entry and follow-up activities for completeness and timeliness
- Closes files according to established guidelines to meet required timelines
- Maintains a working knowledge of company policies and procedures, departmental processes, and associated work instructions
- Evolving local and international regulations, guidelines and applicable directives
- Alcon products for assigned therapeutic area(s) and corresponding documentation (Product Inserts, DFUs, Manuals, Promotional Materials)
- Eye anatomy, common diseases, ophthalmic procedures
- Eye terminology and abbreviations
- Safety databases(s) and reporting tools
- Informs management of potential safety issues, emerging trends and/or concerns
Alcon is an Equal Opportunity Employer and participates in E-Verify. As part of the Novartis Group of Companies, Alcon takes pride in maintaining a diverse environment and our policies are not to discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status. Alcon is also committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please send an e-mail to [email protected] and let us know the nature of your request and your contact information
alrpo EEO Statement The Novartis Group of Companies are Equal Opportunity Employers and take pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status. Minimum requirements •Bachelor’s degree or equivalent years of directly related experience
- 5 years directly related experience
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