Qualified candidates need to have 3 or no less than 2 years of prior PV experience
Need to have prior safety data experience in Argus, ARISg or similar databases.
Prefers a healthcare background in pharmacy, nursing or related area or experience in clinical trials or post clinical trial experience.
Minimum of 40 hour work week with overtime highly possible (OT paid), working either longer days or on Saturdays from time to time (not required).
Nice to have - bilingual in French. This is not required but the hiring manager would like to find someone who also speaks French if possible (not required).
Potential for conversion to permanent based on business needs and performance.
• 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
Product Quality Assurance