Senior Vigilance Reporting Associate - Medical Device (Hybrid) | Cebu - TASQ Staffing Solutions | Career Page

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

Cebu, Philippines

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

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 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.

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