Sunaina Y Email & Phone Number

Princeton, New Jersey, United States

Maintain complaint data, review data for trends and CAPA, ensure effectiveness and adherence to timelines.● As a part of associate responsibility, assigned inquiries to fellow associates ondaily basis using ITRACK system. During system failure, assigned inquiries todesignee department by exporting the queries from the ITRACK system to excelsheet.● Reviewed spontaneous reports as well as cases from clinical trials for marketedand investigational compounds to determine regulatory reporting responsibilities.● Perform SAE reconciliation on a periodic basis and at DLP.● Assisted drug safety team in triaging of ICSRs to determine theirqualification/validity for expedited reporting.● Process adverse event reports received from sites/reporters in Argus safetydatabase and perform QC review of completed individual and periodic safetyreports, and submitting these reports to the regulatory authorities.● Generate adverse event queries.● Hand on experience in Oracle Argus 8 version.● Part of the expert team handling SAE reports especially clinical trial and complex source documents fornarrative writing.● Performed case processing for unblinding reports, duplicate mergers anddeletions, reviewed protocol updates for accuracy and made dechallenge /rechallenge determinations.● Perform Safety Data entry in the database, coding relevant medical terminology,writing a narrative for cases, generating queries pertinent to the case, Evaluation(QC Check).● Coding medical history, drugs, and reported adverse event terms in the safetydatabase using medical dictionaries like MedDRA and WHO-DD.● Initial receipt, database searches as necessary, registry and triage of incomingcases to determine seriousness for prioritizing daily work based on the ICHdates.● Ensure a duplicate check conducted against the Sceptre Safety Database perSOPs for all Individual Case Safety Reports (ICSRs) to determine whether thereis an existing case file.

Bethesda, Md

● Review safety narratives/SAE reconciliations and causality of all serious adverse experiences● Wrote accurate and detailed clinical case narratives ensuring that all the relevant information is presented in the chronological order of occurrence.● Performed quality review for the document discrepancy, to ensure the accuracy of the product compliant data from consumers and internal databases are within specified limits.● Identify and review SUSAR cases, Triaged and coded medical history, laboratory and other investigational test results, adverse event terms using MedDRA and WHO drug dictionary.● Perform quality review of Individual Case Safety Reports (ICSR) which includes a review of source documents and ensuring that the case is accurate and that corrections to the case,if applicable, are incorporated.● Other activities relating to case processing as appropriate per case, including but not limited to Serious Adverse Event (SAE)/Adverse Event (AE) reconciliation.● Perform query for AE reports as required (verbally, email, and in writing)● Distribute PV data and information to Quality, Legal, Regulatory Affairs, or other departments as needed.● Works with colleagues in PV department, regulatory department, and study site staff to facilitate understanding of, and adherence to, protocol requirements for SAE reporting● Participates in study kick off meetings and study specific team meetings as appropriate● Communicates and escalates unresolved safety issues at the appropriate time, and to the appropriate level of management● Trained employees, ensuring adherence to standard operating procedures and establishing protocols.● Management of Individual Case Safety Reports (ICSRs) into the safety database (ARGUS), including triage, duplicate detection, determining the expectedness of serious adverse events (SAE) against various labelling documents.

Masters Of Pharmacy, Industrial Pharmacy

Bachelor Of Pharmacy - Bpharm, Pharmacy