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 Requirements
Years 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.