Alcon Hiring Patient Safety Specialist
Summary Of Position
Responsible for day-to-day case management of quality technical and adverse event complaint 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
- Eafety databases(s) and reporting tools
- Informs management of potential safety issues, emerging trends and/or concerns
Key Requirements/Minimum Qualifications
- Meets internal and external quality standards and achieves required timelines for complaint records management
- Creates high quality complaint records for medical safety assessment and product quality investigation
- Process adherence and outcomes
- Customer satisfaction score
- Bachelor’s degree (healthcare, science emphasis preferred)
- 3-5 years clinical experience – optometric office preferred
- 1-3 years relevant work experience (i.e. device/drug safety, compliance, quality assurance, regulatory affairs
Work hours: 7 PM to 4 AM or 9 PM to 6 AM IST
Relocation assistance: Yes