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.