Savita Waghmare

Experience

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  Qinecsa Solutions

  Apr 2021 - Aug 2022

  (Bioclinica)Data entry and processing.Responsible to review the information auto-populated from Local Intake in Argus.Responsible to review the documents disposed of Local Intake in Argus and perform full data entry of individual case safety reports (ICSR) into the safety database including confirmation of duplicate check performed in Local Intake.Review and evaluate AE case information to determine required action based on and follow internal policies and procedures.Perform the manual coding of adverse events, disease terms, medication, indications, laboratory tests, and non-Baxter products in ArgusGenerate the i-narrative by using the respectively available templates with the information reported without spelling and spacing errors.Assess the reporter causality as per the reporter comments from the source documents for each Product - Event basis if not auto-populated from Local Intake.Assess the Listedness/labeledness for the Adverse Events Reported based on the Reference Safety Information (RSI) or Company Core Data Sheet (CCDS).Perform validation check to ensure no important AE information is missed to enter into the Database. Show less Data entry and processing of individual case safety reports (ICSR). Responsible to review the information auto populated from IRT to ARISg. Responsible to review the documents disposed from IRT to ARISg and perform full data entry of individual case safety reports (ICSR) into the safety database including confirmation of duplicate check performed in IRT. Review and evaluate AE case information to determine required action to be taken based on client policies and procedures. Write the narrative in chronological order by using the respective available templates with the information reported without spelling and spacing errors. Assess the reporter causality as per the reporter comments from the source documents for each Product - Event basis if not auto-populated from IRT. Assess the Listedness/labeledness for the Adverse Events reported based on the Reference Safety Information (RSI) or Company Core Data Sheet (CCDS) as applicable. Perform validation check to ensure no important AE information is missed to enter in the Database. Review each coded MedDRA term and WHO Drug term to ensure accuracy and confirm coding status is resolved.Confirm the correct suspect drug was selected and correct the suspect drug entry if chosen incorrectly by the LPO. Notifies the LPO of the change as applicable.Review the adverse events and assess the seriousness as per Always Serious List, IME list along with reporter seriousness.Evaluate dechallenge and rechallenge information.Perform self-quality checks to ensure all data fields and narratives are correctly populated. Show less 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, and 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, and 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. Show less

  • Jr. Drug Safety Associate

    May 2022 - Aug 2022

  • Jr. Drug Safety Associate

    Feb 2022 - May 2022

  • Jr. Drug Safety Associate

    Apr 2021 - Jan 2022
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  IQVIA

  Dec 2022 - Oct 2023

  Pharmacovigilance Specialist