Drug safety/PV

Drug Safety / Pharmacovigilance (PV) is all about ensuring the safety of medicines — from the first dose in clinical trials to widespread public use. The primary goal is to detect, assess, understand, and prevent adverse effects or any other drug-related problems. Let’s dive into the details:

Responsibilities:

• • Adverse Event (AE) Reporting & Case Processing


• • Safety Data Management


• • Signal Detection & Risk Assessment


• • Risk Management Planning (RMP)


• • Aggregate Safety Reporting


• • Regulatory Compliance & Inspection Readiness


• • Cross-functional Collaboration


• • Patient Support & Product Quality Complaints