Vigilance Reporting Associate - Medical Device

Start Date: ASAP

Work Arrangement: Hybrid (Onsite during probationary period) | Cebu

Type of Support: Voice

Shift: 8PM - 5AM (Weekends off)

Educational Requirement:

• Bachelor's 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.