Senior Drug Safety Associate

Job Overview

Assist with the overall Clinical Safety and/or PSS operations associated with products including the entire adverse events process which may include safety data collected from clinical trials and/or post‑marketing setting (i.e., unsolicited reports). Manage and process expedited adverse events to the required standard and submit them to the client and the regulatory agencies (if required) within the agreed/stated timelines.

Responsibilities

• Manage receipt and processing of all adverse event reports reported spontaneously from any source or solicited from a clinical trial, including safety database entry, AE review, writing patient narratives with coding, follow‑up of missing information, and assessment against appropriate label (for marketed products, if applicable).
• Manage submission of expedited SAE reports to clients, regulatory authorities, ethics committees, investigators, third‑party vendors, partner and Labcorp project pe...