Senior Medical Device Vigilance Analyst — ICSR & QA

TASQ Staffing Solutions; Cebu City; Hybrid; PHP 334,800 - 558,000; Full time

Job summary

TASQ Staffing Solutions seeks a voice support specialist in Cebu City, Philippines. The role involves writing vigilance reports for medical devices, requiring at least 3 years of experience and a Bachelor's degree in related fields. The position is hybrid, allowing for onsite work during the probationary period. Successful candidates will ensure regulatory compliance and quality assurance in medical reporting while demonstrating excellent communication skills. Join a team dedicated to maintaining high standards in patient safety.

Qualifications

• 3+ years of experience in writing vigilance reports for Medical Devices.
• Excellent written communication in English is required.
• Understanding of ISO 13485 and USA Medical Device Regulation is preferred.

Responsibilities

• Collect, enter, and handle safety reports for accuracy and timeliness.
• Validate MedDRA coding and create comprehensive clinical narratives.
• Ensure submission of Individual Case Safety Reports to health authorities.
• Perform quality checks and support audits.

Skills

Writing vigilance reports for Medical Devices

Excellent written communication in English

Understanding of ISO 13485

Education

Bachelor's degree in Nursing, Biology/Microbiology, Electromedical Engineering, Industrial/Mechanical Engineering

Job description

Senior Vigilance Reporting Associate - Medical Device (Hybrid) | Cebu

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

About the job Senior 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 3 years of experience in writing vigilance reports for Medical Devices
• Preferably with good understanding about ISO 13485, USA Medical Device Regulation
  

Job Description:

• Adverse Event Case Processing: Take charge of collecting, entering, and thoroughly handling safety reports to ensure accuracy and timeliness.
• Medical Coding & Narratives: Skillfully validate MedDRA coding and craft comprehensive clinical narratives that tell the full story.
• Regulatory Compliance: Ensure prompt submission of Individual Case Safety Reports (ICSRs) to health authorities, strictly adhering to legal deadlines.
• Quality Review: Perform meticulous quality checks and actively support audits to maintain top-tier compliance standards.
• Mentorship: Inspire and guide junior associates by sharing your expertise in pharmacovigilance processes and industry best practices.