Safety Scientist in Blue Bell, PA at Integrated Resources, Inc

Date Posted: 7/6/2020

Job Snapshot

  • Employee Type:
  • Location:
    Blue Bell, PA
  • Job Type:
  • Experience:
    Not Specified
  • Date Posted:

Job Description

 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.