Nitesh Malkhede

About Nitesh Malkhede

I am Drx. Nitesh M. Malkhede Pharmacovigilance Associate Having an experience as Case Processor ROLE: 1. Enter case data, including but not limited to General information, Reporter details, Patient details, Event details, seriousness, reported causality (when appropriate), medical history, and laboratory data as provided by the reporter. Use MedDRA to code information like specified events, medical history, laboratory data, as applicable, as provided by the reporter. Code products specified as suspect or concomitant by the reporter using Company Drug Dictionary/WHO Drug Dictionary as needed, provide additional details as needed. Enter the narrative, as required, use a lead sentence as appropriate. Self-review AE report data for completeness and verify certain fields to determine as critical (including but not limited to reportability) as well as conformity to E2B standards after completion of data entry. Initiate follow-up activities to obtain additional information and clarification, as appropriate. Forward cases for case review or invalid workflow in the global safety database. • Doing Peer QC for the Local Safety cases, Partner cases, cases from Health Authorities, Pregnancy cases, Pregnancy RMP cases and studies. • Working in global environment: Interacting with other global PV units and local PV representatives around the world. • ICSR quality review for the processed cases. • Being a Subject Matter Expert (SME) for Pregnancy Case Processing and performing pregnancy cases Line Listing for Local Safety reports analysis and Pregnancy AI reports analysis. • Handling of all Pregnancy cases related queries. • Being a Subject Matter Expert (SME) for EudraVigilance Cases triage. • EV related activities (includes EudraVigilance (EV) upload and download, EV Triage, EV - RDA tool, EV Logics, Upload Plan, Assigning EV related tickets to relevant team and approaching EMA service desk as and when required, Uploading XMLs to ESM, Using reports for various purposes, Monthly reconciliation of data from RDA tool, Tool upgrades and updates, etc. • Handling of audit requests. • Handling of CAPA, Deviations, Changes/Updates in SOP. • Any other task assigned by direct manager.

Experience

1. Pharmacovigilance Associate i

   Teva Pharmaceuticals

   Nov 2021 — Present · Bangalore Urban, IN

   Processing ICSR adverse events reports into Global Safety Database.• The different sources / types of reports includes: Reports from the scientific literature, Partners (other pharmaceutical companies), Health Authorities, Pregnancy cases, Pregnancy RMP cases, studies, Clinical Trial cases and other programs.• The processing includes Adverse Events coding (in medical dictionary - MedDRA), drug coding in the Company Product Dictionary and WHO DD, seriousness and labeling assessment and submission to health authorities.• Doing Peer QC for the Local Safety cases, Partner cases, cases from Health Authorities, Pregnancy cases, Pregnancy RMP cases and studies.• Working in global environment: Interacting with other global PV units and local PV representatives around the world.• Working in Literature Manifest Triage Activity along with QC.• ICSR quality review for the processed cases.• Being a Subject Matter Expert (SME) for Pregnancy Case Processing and performing pregnancy cases Line Listing for Local Safety reports analysis and Pregnancy AI reports analysis.• Handling of all Pregnancy cases related queries.• Being a Subject Matter Expert (SME) for EudraVigilance Cases triage.• EV related activities (includes EudraVigilance (EV) upload and download, EV Triage, EV - RDA tool, EV Logics, Weekly Upload Plan, Assigning EV related tickets to relevant team and approaching EMA service desk as and when required, Uploading XMLs to ESM, Using reports for various purposes, Monthly reconciliation of data from RDA tool, Tool upgrades and updates, etc.• Handling of audit requests.• Handling of CAPA, Deviations, Changes/Updates in SOP.• Any other task assigned by direct manager.

Education

• Savitribai Phule Pune University

  Bachelor of Pharmacy - BPharm, Pharmaceutical Sciences, Distinction

  2012 — 2016