Vigilance Reporting Associate Medical Device
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Job Location:
Cebu - Philippines
Monthly Salary:
Not Disclosed
Posted on:
8 hours ago
Vacancies:
1 Vacancy
Job Summary
Start Date: ASAP
Work Arrangement: Hybrid (Onsite during probationary period) Cebu
Type of Support: Voice
Shift: 8PM - 5AM (Weekends off)
Educational Requirement:
- Bachelors degree in Nursing Biology/Microbiology Electromedical Engineering (Biomedical Engineering) Industrial/Mechanical Engineering or other education/science/technology related discipline desired
Qualifications:
- At least 2 years of experience in writing vigilance reports for Medical Devices in a shared services/KPO/BPO/call center environment
- Excellent written communication in English
- Good understanding about ISO 13485 USA Medical Device Regulation
Job Description:
- Medical Complaints Specialist/Investigator: Expertly drafts and submits Medical Device Reports (MDRs) conducts comprehensive product safety literature reviews and meticulously manages all complaint documentation to ensure quality and compliance.
- Vigilance Reporting: Takes charge of preparing detailed monthly vigilance reports for the EMEA region ensuring timely and accurate safety monitoring.
- Pharmacovigilance/Drug Safety: Handles the processing of Individual Case Safety Reports (ICSRs) and performs thorough case triage to support drug safety initiatives.
- Medical Associate (Cebu/Manila): Efficiently manages customer complaints evaluates reportability of Medical Device Reports (MDR) and guarantees adherence to all compliance standards.
