Job Information
ZYDUS PHARMACEUTICALS USA, INC. Drug Safety Associate in PENNINGTON, New Jersey
Intake and follow up Adverse Events (AE) and record the discussion in relevant AE worksheet. Evaluate cases for seriousness and expectedness criteria, distribute AE reports to plant QA/GPV/Partner companies in accordance with Safety Data Exchange Agreements (SDEAs), & take appropriate decisions by applying knowledge of FDA/ICH GCP/GVP standard regulations. Perform pharmacovigilance reconciliation of databases and listings, implement and execute QC on key fields for serious cases, & develop, implement and manage appropriate SOPs and systems to track and manage product-associated events.