Job Description

Role Purpose

The purpose of the role is to provide effective technical support to the process and actively resolve client issues directly or through timely escalation to meet process SLAs.
 

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Target Profiles:

1. Experience in Ophthalmology (Required)
2. Experience in Health Authority Reporting (Preferred)
3. Experience in Medical Writing (Preferred)
4. Experience in Medical Device Complaint Handling (Preferred)

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Overview of roles and responsibilities:

1. Subject Matter Expert
2. Oversees Customer Quality Specialists under her span
3. Participates/presents during governance or business reviews as maybe required
4. Trains new team members as required
5. Medical Device Complaint Handling: Surgical Vision Care

• Complaint file management
  • Manage and process approximately 500 complaint files per month from the intraocular (IOL) product line, which can include literature complaints.
  • Perform file processing activities in a timely manner per Buyer’s policies and procedures, including coding, reportability determination for all relevant health authorities, and investigation determination.
  • Obtain relevant complaint information through product complaint follow-ups with maximum three attempts per Buyer’s policies. Enter complaint information into the Buyer complaint management system in a timely manner and in accordance with Buyer’s complaint management policies and procedures.
  • Close the complaint in accordance with Buyer’s complaint management policies and procedures.

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• Regulatory reporting
• Generate/created regulatory reports as required for the event if determined reportable.
• Draft and submit approximately 70 regulatory reports from APAC region to the health authorities using the Buyer complaint management system
• Draft approximately 100 MIR monthly Vigilance reports from EMEA region
• Draft and/or Submit approximately 200 MDRs as defined by the Buyer
• Literature Review
• Literature articles are received via e-mail, direct communication from the customer, Buyer employees or through Buyer’s literature search team
• Performs literature article review using the Buyer complaint management system
• Performs the complaint entry and intake process resulting from the literature article reviews using the Buyer complaint management system for identified business unit of Buyer
• Conduct review of literature articles received and complete intake of new events or update existing records for additional information taken from the literature article reviews

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