Job Description: As a Pharmacovigilance Scientist (Position Code: PVS001), your primary responsibility will be to manage activities related to adverse event (AE) and serious adverse event (SAE) processing, follow-up, analysis, and regulatory reporting for both marketed and investigational human and veterinary products, adhering to applicable regulatory requirements. Additionally, you will be responsible for the preparation of aggregate reports such as Periodic Benefit Risk Evaluation Reports (PBRERs), Periodic Safety Update Reports (PSURs), Addendum to Clinical Overviews (ACOs), Addendum PSURs, PSUR Line Listings, and US Periodic Adverse Drug Experience Reports (PADERs) from aggregate data, following client conventions and requirements. You will also conduct quality checks of aggregate reports and perform signal detection-related analyses and reports, including cumulative analyses and issue event analyses.
Minimum Qualifications: