Pharmacovigilance Associate
Virtual Vocations Inc, New York, NY, United States
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
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