Drug Safety Specialist (contract)

Duration of Contract: 1 Year

Hours:  9:00 – 5:00

Pharmacovigilance Associate for Operations is working with a number of clinical study teams. Serious Adverse Event (SAE) reconciliation, safety study plans, working closely with a case management team, as well as working cross-functionally with clinical study teams. This is not a case-processing role.

Experience in DSUR prep is helpful. Contributing to documentation, not authoring documents. Most of the clinical study-specific safety plans are ‘template-driven’, not authoring of the documents.

Experienced with Argus Database

Global regulatory reporting/compliance

Understanding of MedDRA coding conventions

Ensures follow-up and query process

Vendor oversight