Damini Shelar

Safety Scientist @UBC

US

Responsible for processing and evaluating (i.e. narrative writing, seriousness, causality and expectedness assessment) safety reports originating from clinical studies, literature and the post marketing experience for client products. • Responsible for the timely completion of safety reports for distribution to Health Authorities, clients and client’s partners. • Responsible for the timely identification of Safety Reports and/or relevant safety information during the monitoring of the literature. • 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 reports, aggregate data, line listings. • 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. • Assist with the preparation of relevant project specific plans and procedures and other plans linked to case processing and literature activities as required and assigned by UBC PV Management. • Participates in project specific internal teleconferences/meetings and client specific teleconferences/meetings for operations. • Provide and assist with appropriate documentation of non-compliance with regulatory requirements and / or applicable procedures in Safety Incident Reports (SIRs), Problem Notification Forms and Corrective and Preventive Actions (CAPA) as required. • Support in client audits and regulatory inspections from a pharmacovigilance operations standpoint. • Other duties as assigned by UBC PV Management.