Puneet Kumar Email & Phone Number

Ahmedabad, Gujarat, India

New Delhi Area, India

Entering source data in the database, Coding, Narrative(s) writing and Generate Follow-up letters.Involved in generating listing and authoring PADER.Involved in reviewing PADER cases.Carry out follow-ups of case reports by contacting the reporter, to ensure maximum collection of data.Book in and Triaging of lCSRsReview of literature articles and assessment for identifying valid lCSRsMaintain awareness of changes to/new regulations affecting PVG activities.To carry… Show more Entering source data in the database, Coding, Narrative(s) writing and Generate Follow-up letters.Involved in generating listing and authoring PADER.Involved in reviewing PADER cases.Carry out follow-ups of case reports by contacting the reporter, to ensure maximum collection of data.Book in and Triaging of lCSRsReview of literature articles and assessment for identifying valid lCSRsMaintain awareness of changes to/new regulations affecting PVG activities.To carry out necessary administrative duties required for the job.Other duties as assigned by management.Execution of Company Standard Operating Procedures.Assignment of the cases for data entry and triageInvolved in CAPA activity, performing QC of the cases involved in CAPA and make the suitable changes requiredQuality review of the casesEmbase Primary and secondary review for literature cases. Show less

New Delhi Area, India

Bangalore

Handling of clinical trial Serious and non-serious adverse events.Perform initial evaluation and data entry of all SAEs.Data entry and coding of adverse events from clinical trials phase 1-4 based on individual case histories, correspondence with affiliates, other departments and various administrative assignments.Data verification between source data and Argus database.Ensure accurate and consistent coding of all events entered in Argus with the use of MedDRA (Medical… Show more Handling of clinical trial Serious and non-serious adverse events.Perform initial evaluation and data entry of all SAEs.Data entry and coding of adverse events from clinical trials phase 1-4 based on individual case histories, correspondence with affiliates, other departments and various administrative assignments.Data verification between source data and Argus database.Ensure accurate and consistent coding of all events entered in Argus with the use of MedDRA (Medical Dictionary for Regulatory Activities).Evaluate seriousness, causality and listedness.Assess the need for follow up information and issue or draft follow up requests, as applicable.Archiving of cases in Argus.Act as a mentor for Junior colleague.Perform initial evaluation of spontaneously reported non serious adverse events including reports from post marketing surveillance studies.Perform data entry of adverse events from spontaneously reported non serious including reports from non-interventional source.Ensure that all tasks are performed in accordance with GXP (Good Practices) requirements. Show less

Bangalore

Handling of clinical trial Serious and non-serious adverse events and MESIs:Perform initial evaluation and data entry of all SAEs and MESIs.Perform medical evaluationEnsure appropriate medical interpretation and evaluation of adverse events reported from clinical trials. Medical evaluation comprises the following responsibilities:Verify correct transfer of data from source to database.Ensure accurate and consistent causality assessment and listedness as well as coding… Show more Handling of clinical trial Serious and non-serious adverse events and MESIs:Perform initial evaluation and data entry of all SAEs and MESIs.Perform medical evaluationEnsure appropriate medical interpretation and evaluation of adverse events reported from clinical trials. Medical evaluation comprises the following responsibilities:Verify correct transfer of data from source to database.Ensure accurate and consistent causality assessment and listedness as well as coding of adverse events entered in Argus with the use of MedDRA (Medical Dictionary for Regulatory Activities).Ensure that case narratives comprise correct and exact safety information.Ensure that case narratives are well structured and consistent.Evaluate the need for follow up information and query the follow up information in EDC or via other appropriate route. Act as a mentor for Junior Clinical Safety Associate. Show less

Master Of Business Administration - Mba, A

Master Of Pharmacy, Pharmacology

Activities and Societies: Worked on Diabetic neuropathy

High School, High School/Secondary Diplomas And Certificates

Activities and Societies: Schooling and Sports