ANKITA PATHAK

4.5 years of experience in Pharmacovigilance Case processing, ICSR signal detection using ICHGCP guidelines, complaint handling, adverse event coding using MedDra,Medical Devices and reporting to FDA (Regulatory Body). Currently working in IQVIA as Pharmacovigilance Operations Specialist 1 (Quality Auditor), formerly worked at COGNIZANT.

• Lax Diabetes Desktop
• Gandalf
• SAP Logon

• I'm the only member in my grade working in Finalization along with associates of two grades above me.
• Top rated performer in my team.
• Well versed in all three workflows i.e. DE, QC and Finalization.
• Finalization being my core workflow have provided support to other two other workflows on lean staffing days and as and when required.
• Have managed additional activities like mentoring the freshers, case assignment, contact log activity for KPI calculations, drawing out listedness for country specific products, late case analysis, action item due date calculation, etc.
• Experienced in Pharmacovigilance as well as Medical Device case processing.

• Finalization (Core workflow)
• Mentoring (additional)
• DE AND QC (support if required)
• Review/ Reassessment
• FUDR (Follow-up Device Return)
• DHR (Device History Record)
• MDR (Medical Device Reporting)
• Supplemental (Follow-up report to CDRH)
• Complaint Investigation
• Follow up Report

• Insulin pump (Model- MMT-1880, MMT-1712K)
• Reservoirs (Model- MMT-332A, MMT-326A)
• Sensors (Model- Guardian Sensor MMT-7020A and MMT-7020LA)
• Infusion set (Uno medical product)
• Accessories (Clip, Tape)
• Transmitter (Model-MMT-7811NA, MMT-7911NA)

• IQVIA, FINALIZATION, It involves checking of mandatory fields, CAT 1 errors, country specific validations, entering of state codes, removing validation errors, removing negative acknowledgment errors, narrative formats, Action items, queries and due dates, MR corrections and then pushing the case to next workflow.
• IQVIA, QC, Have provided support to QC workflow as and when required which involved cross checking of data captured by DE associates like checking Report type specific conventions, IRD, CRD, country specific products if company or non company, event coding, product coding, narrative format and action items.

• Argus
• Smartsolve
• Citrix
• USPI
• CDPI
• CDS
• REVA
• Veeva Vault
• IPL (for full product authorization report)
• VAP (for partner agreements)
• Agile (Quality Management System)
• VMware Horizon
• Salesforce
• SmartSolve
• SSIT
• Smartsheet

• Performing Finalization of cases and Quality Auditing (locking the cases and pushing to Regulatory Reporting Team after checking of mandatory errors), after the case passes from DE and QC workflow.
• Capturing and assessing single adverse event reports associated with client products on a worldwide basis on the client's drug safety database, in accordance with international and local regulatory requirements.
• Faced client audits and MHRA audits.
• Management of ICSRs of all case types (serious and non-serious cases from spontaneous and solicited programs, clinical trial cases, regulatory authority cases, literature and E2B cases) including triage of confidential to determine whether they qualify for expedited reporting or not and the timelines within which they need to be submitted to the regulatory authorities.
• Conducting duplicate searches prior to initiation.
• Good understanding of the quality and confidentiality of patient data process involved in processing the data to make it presentable to regulatory requirement.
• Performing correction of cases after the case gets routed back from RR.
• Performing Deletion Assessment judgement for cases being sent to deletion workflow.
• Provide training and mentorship to new pharmacovigilance team members on processes and regulatory requirements.