Quality Review and Submissions (ICSR)

Quality Review and Submissions (ICSR)

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 Requirement

Pharmacovigilance (PV), specifically in ICSR Quality Review and Regulatory Report Submissions

Hands-on experience with the Argus Database is essential.

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. .