Quality Review & Regulatory Report Submission Specialist
Company: Vizen Life Sciences Pvt Ltd
Location: [City, Country]
Employment Type: Full-Time
Position Overview
Vizen Life Sciences is seeking an experienced Quality Review & Regulatory Report Submission Specialist to ensure accurate, timely, and compliant submission of pharmacovigilance reports to Health Authorities. The ideal candidate will have 4–6 years of experience in ICSR quality review and regulatory reporting, with hands-on expertise in the Argus database.
This role is critical in maintaining regulatory compliance, supporting global PV operations, and ensuring adherence to internal and external reporting timelines.
Key Responsibilities
Review, approve, and schedule ICSR reports in the Argus database for submission to relevant Health Authorities.
Submit cases and regulatory reports to Health Authorities, business partners, and affiliates as required.
Ensure compliance with internal and external timelines for case processing and regulatory reporting obligations.
Monitor and maintain regulatory reporting schedules, ensuring all submissions meet Health Authority requirements.
Support quality assurance activities related to ICSR review and report submissions.
Required Qualifications & Experience
Educational Background: B.Pharm or M.Pharm.
Experience: 4–6 years in Pharmacovigilance (PV) with a focus on ICSR quality review and regulatory report submissions.
Hands-on experience with Argus Safety Database is essential.
Key Skills & Competencies
Strong knowledge of global pharmacovigilance regulations and Health Authority submission requirements.
Expertise in quality assurance, compliance, and data integrity.
Excellent attention to detail, analytical, and problem-solving skills.
Strong communication, coordination, and time management abilities.
Ability to work independently while meeting strict regulatory timelines.
Why Join Vizen Life Sciences?
Work in a globally compliant PV environment supporting multiple markets.
Contribute to regulatory reporting excellence and patient safety initiatives.
Opportunity to develop expertise in ICSR review, Argus database management, and Health Authority submissions.
Keywords optimized for SEO/GEO: Pharmacovigilance jobs, ICSR quality review, Regulatory report submission specialist, Argus database expert, Health Authority compliance, PV careers.
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