Deepika Shukla

Patient Safety Specialist @IQVIA

Reading, GB

As part of the US Patient Safety Operations team, managed multiple US Patient Safety mailboxes for addressing AE Reports and Queries, and handled each accurately per local SOPs, Work Instructions, Job and Guidance.Prepared accurate and timely US regulatory submissions to the FDA for AE reports meeting US FDA expedited reporting criteria for IND cross-reporting SUSARs by completing Cover Letters and Form 1571 for respective IND and corresponding cross-reporting INDs. Monitored US Submissions and Submissions-related Queries mailboxes. Monitored Safety Database and Local Reports to identify failed submissions:* For failed submissions due to technical issues, coordinated with the local Systems team for resolution and successful resubmission.* For failed submissions due to NACKs, reviewed the case and coordinated with case owners to perform necessary corrections before successful manual resubmission.* Coordinated with the local PV Compliance team to investigate the root cause of late report submissions. Prepared US Investigator Safety Letters (ISLs) for onward distribution to the US Investigators. Conducted periodic reconciliations and addressed discrepancies via cross-organizational and cross-functional email communication for processed and unprocessed AE data exchanged between AstraZeneca and its US Vendors per US Licensing Agreements. Led reconciliation training based on current local processes. Ensured AE Reports managed through the mailbox were handled appropriately by the case processing team by reconciling each report.* Ensured AE Reports managed through the mailbox were handled appropriately by the case processing team by reconciling each report periodically.* Led and assisted process efficiencies for periodic AE data reconciliations.Led and assisted in updates to local job aids and work instructions based on process updates.Assisted in cross-functional Pharmacovigilance (PV) projects.

Banasthali Vidyapith

M.Pharm