Pharmacovigilance Associate

Job Summary

A company is looking for a Drug Safety Associate II to manage and evaluate adverse event reports for investigational and marketed products.

Key Responsibilities

• Process individual case safety reports (ICSRs) and ensure quality and timely submission
• Perform quality checks on assigned ICSRs and reconcile safety data
• Participate in Study Team meetings and support audits and regulatory inspections

Required Qualifications

• Degree in Pharmacy (PharmD) or Nursing (RN) required
• Minimum of 2 years' experience in the pharmaceutical industry, preferably in Pharmacovigilance
• Understanding of safety report assessment and regulatory reporting obligations
• Working knowledge of drug safety databases (preferably ARGUS) and MedDRA
• Flexibility to work in a fast-paced environment with strong organizational skills