20 Sep
|
Vizen Life Sciences
|
Hyderabad
20 Sep
Vizen Life Sciences
Hyderabad
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:
Solid knowledge of PV regulations and guidelines for Health Authority submissions.
Expertise in quality assurance and compliance.
Excellent attention to detail and analytical skills.
Robust communication and time management abilities.
📌 Quality Review And Submissions Icsr Hyderabad
🏢 Vizen Life Sciences
📍 Hyderabad