Medical Device Vigilance Reporter - MDR & ICSR Expert

TASQ Staffing Solutions; Cebu City; Hybrid; PHP 334,800 - 446,400; Full time

Job summary

TASQ Staffing Solutions is looking for a Medical Complaints Specialist in Cebu City. The role involves drafting and submitting Medical Device Reports (MDRs), managing safety monitoring through vigilance reporting, and processing Individual Case Safety Reports (ICSRs). Candidates should possess a Bachelor's degree in Nursing, Biology, or Engineering and have at least 2 years of relevant experience. The work arrangement is hybrid, with an onsite requirement during the probationary period.

Qualifications

• At least 2 years of experience in writing vigilance reports for Medical Devices.
• Excellent written communication in English required.
• Good understanding of ISO 13485 and USA Medical Device Regulation.

Responsibilities

• Draft and submit Medical Device Reports (MDRs) and manage complaint documentation.
• Prepare detailed monthly vigilance reports for the EMEA region.
• Process Individual Case Safety Reports (ICSRs) and perform case triage.

Skills

Written communication in English

Understanding of ISO 13485

Experience in vigilance reporting

Education

Bachelor's degree in Nursing/Biology/Microbiology/Engineering

Job description

Vigilance Reporting Associate - Medical Device (Hybrid) | Cebu

Job Openings Vigilance Reporting Associate - Medical Device (Hybrid) | Cebu

About the job Vigilance Reporting Associate - Medical Device (Hybrid) | Cebu

Start Date:ASAP

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

Type of Support:Voice

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
• 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.