- 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 to 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.Pharmacy / M.Pharmacy
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.
- Strong communication and time management abilities.
📌 Drug Safety Associate ( Quality Reviewer & Submissions) (Hyderabad)
🏢 Vizen Life Sciences
📍 Hyderabad
Reply to this offer
Impress this employer describing Your skills and abilities, fill out the form below and leave Your personal touch in the presentation letter.