Senior Vigilance Reporting Associate Medical Device
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Job Location:
Cebu - Philippines
Monthly Salary:
Not Disclosed
Posted on:
6 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 3 years of experience in writing vigilance reports for Medical Devices
- Excellent written communication in English
- 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.
