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Green Key Resources

Safety Scientist

Post Date:Dec 27, 2017Type:Contractor
Start Date:12/27/2017Salary:
Location:US-PA-Blue Bell Job Reference:

Scientific 4 year degree

3+ years safety experience

- Need to have narrative abilities
- Will have interaction with Medical Review point of contact
- Oncology would be "nice to have"

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

Contact Information
Green Key Resources

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