Drug Safety Associate ( Quality Reviewer & Submissions)

Vizen Life Sciences

4 - 6 years

5 - 15 Lacs

hyderabad

Posted:1 day ago| Platform:

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Skills Required

drug safety associate drug safety pharmacovigilance icsr aggregate reporting psur medical writing pbrer case processing quality reviewer argus medical research

Work Mode

Work from Office

Job Type

Full Time

Job Description

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 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:

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.

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