Safety Scientist

* Assist with the preparation of adverse event reporting plans (AERPs) and other plans as required
* Maintain a listing of all administrative changes and updates
* Ensure all processes as described are operational
* Alert Project Management when activities fall outside SOW
* Process and evaluate AE reports according to the customer's standard operating procedures (SOPs): write the narrative, perform seriousness rating and causality and expectedness assessment
* Ensure the quality and accuracy of data used to support any regulatory document, including but not limited to: ICSRs, aggregate data, requested line listings
* Assist in the reconciliation of clinical and safety databases
* Contribute to the preparation and quality control of safety aggregate reports, responses to authorities, company core data sheets, signal detection and assessment reports
* Perform literature review for identification of case reports and other relevant safety information
* Liaise with both internal and external vendors (clients, patients and HCPs)
* Review/Quality check (QC) of source documents, coding, data entry, report generation and distribution
* Monitor compliance metrics and ensure appropriate documentation when deficient
* Assist in evaluation and validation of systems to support safety
* Other duties as assigned by management
To find out more about Real please visit www.realstaffing.com