Drug Safety Specialist
About this role
Drug Safety Specialist
The Drug Safety Specialist will have primary responsibility for the following:
- Case Processing (CT/ PM) – 50% Responsible for the processing adverse event reports that include but not limited to the receipt, evaluation, reviewing and reporting of adverse event information for marketed and investigational products in accordance with ICH guidelines and applicable regulatory requirements including the FDA, company SOPs, and applicable licensing or partnership agreements.
Track cases from receipt to closure and work with clinical, regulatory, and contract research organizations (CROs) to ensure that all post-market and clinical safety pharmacovigilance activities are performed across ongoing projects independently.
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