Sign up with

Already have an account? Log in here

Need some help?
Talk to us at +91 7670800001

Senior Vigilance Reporting Associate - Medical Device (Hybrid) | Cebu at Tasq Staffing Solutions, Inc.

City of Cebu, Cebu, Philippines -

Full Time

Start Date

Immediate

Expiry Date

11 Aug, 26

Salary

0.0

Posted On

13 May, 26

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Vigilance Reporting, Medical Device Safety, MedDRA Coding, Clinical Narratives, Regulatory Compliance, ICSR Submission, Quality Review, Pharmacovigilance, ISO 13485, USA Medical Device Regulation, English Communication, Case Processing

Industry

Staffing and Recruiting

Description

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.

Responsibilities

Manage the collection and processing of adverse event safety reports and create comprehensive clinical narratives. Ensure regulatory compliance through timely ICSR submissions and provide mentorship to junior associates.