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vizenlifesciences

Posted 30 Sep 2024

Quality Review & Regulatory Report Submission

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Employment
Full time
Team
ICSR Management
Posted
30 Sep 2024

About the role

Key Responsibilities*Approve and schedule reports in the Argus database for submission to respective Health Authorities, as applicable.*Submit cases to Health Authorities, Business Partners, and Affiliates as required.*Ensure adherence to internal and external timelines for case processing to maintain regulatory reporting compliance.*Schedule and approve regulatory reports based on reporting obligations.
Job RequirementsYears of Experience: 4–6 years of relevant experience in Pharmacovigilance (PV), specifically in ICSR Quality Review and Regulatory Report Submissions.Hands-on experience with the Argus Database is essential.
Educational Qualification:B.Pharm / M.Pharm
Skills and Competencies:Strong knowledge of PV regulations and guidelines for Health Authority submissions.Expertise in quality assurance and compliance.Excellent attention to detail and analytical skills.Strong communication and time management abilities.

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