Charan Dev Email & Phone Number

Los Angeles, California, United States

Performed complete processing of an Individual Case Safety Reports (ICSR) case including receipt, triage, duplicate-check, book-in, case processing, Narratives, Follow up’s, Quality check and Submissions of ICSRProcessed initial and follow-up information for both serious and non-serious adverse events in safety database (Argus) followed by writing an event description (Narrative) using company’s template.Reviewed adverse event forms for completeness & validity.Performed a review of ancillary documentation accompanying adverse event reports and identifies pertinent clinical information to enter into company’s drug safety database.Performed coding for adverse events using MedDRA, suspect drug using company dictionary, and concomitant medications using WHO dictionary.Performed Quality Review of peer’s cases and cases from CRO for accuracy and completeness of MedDRA coding, seriousness, expectedness, data entry, and narrative. Determined and performed follow-up for missing, discrepant or additional information for each case, and document results in case file. Created narrative templates and written narratives for Clinical Study Report (CSR)Performed SAE reconciliation to check the discrepancy between clinical and safety database.

Richmond, Virginia, United States

Performing triage by assigning priority to time sensitive and project critical incoming events and classify them according to regulatory reporting criteria.Processing and assigning cases in the validated database by performing assigned roles (data entry, safety processing, and safety reporting) within Global and local timelinessPerforming Duplicate Search to refrain from multiple case entrees.Efficient in entering SAE report data (initial and follow-up reports) into SAE tracking database simultaneously tracking generated case ID numbers.MedDRA coding of SAEs and AEs as reported in source documents of SAE reports and developing with simultaneous revision of MedDRA Coding Conventions to ensure consistent data categorization.Composing descriptive and scientifically sound Narrative Writing Submitted necessary SAE report queries (internally generated or from pharmaceutical partners) to study site and also succeeded in tracking for resolution.Performed quality control of information entered into the safety database for completeness and coherency.Assisting with SAE reconciliation in conjunction with Data Management team (SAE Reconciliation of safety database with clinical database (Inform). Producing preliminary draft expedited report(s) (e.g., MedWatch, CIOMS - I) for any SAE report which meets expedited reporting criteria; yet times also finalized report for submission after Sponsor review/approval.Assisted in preparing the periodic safety update reports and IND annual reports (ASUR and DSUR).Assisted in generating line listing of all non-expedited reports (PSUR and annual reports).Circulates aggregate reports/PSUR/DSUR for team review and quality control/quality assurance.Update the document reconciling the reviewers'/auditors' comments and resolving inconsistencies.Assisting in ensuring that all deliverable s are provided (aggregate reports) on the appropriate milestone date abiding internal & regulatory timelines.

Horsham, Pennsylvania, United States

Received, tracked, and assessed SAE report from all sourcesCoordinated Due Diligence responses and distribution to the appropriate databaseIndependently evaluated case source, SAE, and patient information to determine report status (initial vs. follow-up), expedited, not expeditedBook-in of new adverse events in the drug safety database and sending acknowledgments to clientsAssessed SAE reports for completeness and search multiple databases for duplicates and enter all applicable data into safety database including medical history, suspect/concomitant drugs, report source, and patient demographicsWorked on reconciliation for coded information between safety database and clinical database and generating queries and follow-upPerformed compliance monitoring task to evaluate the individual and overall lateness reason for cases processed outside of ICSR timelines or submitted outside of timelines to the licensed partner and regulatoryResponsible for maintaining query mailbox within the department to meet compliance of casesPerformed follow-ups with reporters via eFax, email, and telephone.Gathered all the information required to be the case and request critical missing information by contacting the reporterParticipated in department projects as required

Bengaluru, India

Collected, documents, and processed adverse event (AE) reports from clinical trials and post-marketing sources adhering to Standard Operating Procedures (SOP) Individual case assessments in relevance to seriousness and expectedness of adverse events were determinedUsing the safety database system and other tracking tools, documented adverse event information and case processing activities Performed medical coding using MedDRA and WHO-Drug dictionariesPrepared clinical narrative summaries for ‘Adverse Event’ Performed active follow-up via telephone contact with consumers and health care professionalsIdentified case assessment related problems and reviewed reportsPerformed effectively on assigned cases

InternshipAssisted in Case Processing & reporting Adverse events.Assessment of causality, seriousness and expectedness of adverse drug reactions/adverse event reports.Perform processing and oversight of adverse event/drug experience reports (serious and non-serious) and other safety related data for marketed products and clinical trials.Responsible for Adverse event coding using standardized terminology from a medical coding dictionary, such as MedDRAAssist in analyzing and processing safety reports of Serious Adverse Events (SAEs).Participated in writing narratives, submitting case to medical reviewer in Argus database.