Reena Grewal

Master's

Public Health

United BioSource

Safety Scientist Global Case Processing

- Responsible for processing and evaluating (i.e. narrative writing, seriousness, causality and expectedness assessment - Responsible for the timely completion of safety reports for distribution to Health Authorities, clients and client's partners - Responsible for Quality Control of Case Processing and Literature Review deliverables - Ensure the quality and accuracy of data used to support any regulatory document, including but not limited to: safety - Ensure the timely and accurate completion of case processing due diligence activities - Ensure the timely and accurate completion of PV reconciliation activities - Assist in the reconciliation of clinical and safety databases - Prepare and follow through to completion the Safety Database requests (case deactivation, Output Request, Change Control and User Access Request Forms as appropriate) for UBC PV management review and approval - Prepare and submit weekly, monthly and quarterly line listings for project specific activities. Prepare CCIDs and submit monthly line - Participates in project specific internal teleconferences/meetings and client specific teleconferences/meetings for operations - Escalates to UBC PV Management when activities fall outside contracted tasks in Scope of Work (SOW) or applicable - Provide and assist with appropriate documentation of non-compliance with regulatory requirements and / or - Support in client audits and regulatory inspections from a pharmacovigilance operations standpoint - Other duties as assigned by UBC PV Management