Job Description:
This role oversees processes and systems for initial intake of adverse event data and subsequent reporting of Individual Case Safety Reports (ICSRs) to health authorities and internal destinations. The position leads a global team responsible for all aspects of intake and ICSR submissions for the company product portfolio.
Key Responsibilities:
* Oversight of all aspects of intake responsibilities for ICSRs, including management of applicable vendors.
* Servicing as subject matter expert for audits and inspections on ICSR intake and submission.