Tarakanta Behera Email & Phone Number

Ahmedabad, Gj, In

Ahmedabad, Gujarat, India

• Submission to MHRA, FDA, CDSCO and tracking acknowledgement • Oversight of ICSR submission related activities including retrospective review of ICSR submissions, manual submissions, track and maintain submission trackers.• ICSR follow-up oversight including monthly report extraction from ARGUS database, prepare to identify the non compliant action items specific to affiliates, obtain feedback from affiliates, review and prepare final metrics and present in quality forums.• Significant contribution to the strategy, draft and review of follow-up oversight activity.• Responsible for generating, preparing appropriate Clinical queries and Post marketing follow-up queries and requests for clarification of additional data.• Facilitate follow-up based on queries from Data entry/QC/MR or based on inconsistent/missing information in the source file.

Ahmedabad, Gujarat, India

Triaging, Case Processing:Confirm validity of case by identifying minimum criteria for case creation.Perform duplicate search to create either an initial case or a follow-up case.Identify serious adverse events and special scenario cases which includes lack of efficacy, exposure,and pregnancy case, at risk cases, and product quality complaint only cases.Deletion and nullification of the cases.Clinical assessments which include event selections and case seriousness.Responsible for writing or reviewing medically relevant safety narratives of cases and checking thecompleteness and accuracy of the data entered in the various fields.using standardized terminology from a medical coding dictionary, such as MedDRA, CompanyProduct Dictionary, WHO-DD.Performs clear and accurate data capture of cases following client conventions/guidelinesand Standard Operating Procedures (SOPs).Ensures that the expectedness, causality assessment, as well as seriousness criteria, areaccurate for the events.Literature search & monitoring:To perform initial review of literature articles, retrospective reviews, local literatures, Safety Dataexchange reports, digital media and segregating them into ICSRs, AOIs, on hold and not selectedbased on information provided in the article.Medical enquiry:Handle medical, pharmaceutical, and technical enquiries, including adverse events (AE).Ensure that enquiry is responded within defined timelines.Address live calls from consumers, healthcare professionals, patients and/or investigators seekingproduct and medical information.Receipt and reply to enquiries.Maintenance and documentation of received enquiries.Reconciliation of received enquiries with safety database (as applicable) and with client/affiliates/business partners to ensure that all relevant safety information is transferred.

Master'S Degree In Pharmaceutical Analysis & Qa, Pharmaceutical Sciences, First

Bachelor Of Pharmacy - Bpharm, Pharmaceutical Sciences, First