YADAV SAURABH

Experience

• 

  Tata Consultancy Services

  Sept 2020 - now

  As a Case Processor:• Duplicate/Invalid ICSR Handling: Identifying duplicate or invalid Individual Case Safety Reports (ICSRs) and managing them according to SOPs.• Adverse Event Processing: Reviewing, assessing, triaging, processing, and reporting adverse event reports within regulatory timelines, adhering to safety guidelines.• Diverse Report Processing: Handling clinical trials, Licensing partner (LP), Legal, Listing/Aggregate, and Literature reports (both Expedited and Non-Expedited) from various sources like Jasper, E2Bs, articles, and clinical databases.• Source Document Review: Assessing source documents, compiling data from eCRFs, and evaluating seriousness, case validation, causality, and expectedness for triaging and categorization.• Special Scenario Analysis: Analyzing AE reports involving special scenarios like medication errors, overdoses, and pregnancy cases and processing them accordingly.• Data Entry and Coding: Performing end-to-end data entry, including coding of medical terminology, concomitant medications, and relevant medical details using MedDRA and WHO-DD.• Narrative Writing: Crafting descriptive narratives for applicable ICSRs.• Timely Case Closure: Ensuring timely closure of cases.As a Case Assignment Person:• Daily Case Assignment: Responsible for daily case assignment for the entire Clinical Trials (CT) team.• Team Coordination: Assigning cases to data entry and Quality Review and Evaluation (QRE) teams, maintaining workflow timeliness.As a Quality Reviewer and Mentor:• Risk Mitigation: Minimizing risk through active collaboration with Quality Standards and engaging with management when necessary.• Training and Mentorship: Conducting training sessions for new associates and acting as a mentor within the team.• Quality Evaluation: Performing thorough quality reviews and discrepancy analyses across critical domains, including narrative composition and patient safety details. Show less As Case Processor:• Identification of Duplicate/Invalid ICSR: Identifying duplicate or invalid Individual Case Safety Reports (ICSR) in Sapphire and handling them according to the relevant Standard Operating Procedure (SOP).• Assessment of Adverse Event Reports: Evaluating adverse event reports and assessing their regulatory status, including seriousness and expectedness/relatedness. This assessment helps prioritize workload and ensures timely submission.• Causality Assessment: Assessing causality according to the WHO causality scale and determining the expectedness of adverse events based on labeling documents such as Investigator's Brochure (IB), Reference Safety Information (RSI), and Summary of Product Characteristics (SMPC).• Processing of ICSR: Handling spontaneous and solicited cases, both expedited and non-expedited, received from various sources such as Jasper, E2B, MC, and Licensing partners in the Sapphire safety database.• Query Generation: Responsible for generating and forwarding appropriate queries and requests for clarification when encountering discrepant data or requiring additional information.• Safety Narrative Writing: Authoring medically relevant safety narratives for cases and verifying the completeness and accuracy of data entered in various fields.As Quality Reviewer:• Data Review: Conducting a comprehensive review of data entered into the safety database to ensure completeness and accuracy.• Quality Feedback: Providing constructive quality feedback to team members and resources involved in the case processing process.• Quality Metrics: Monitoring and maintaining quality metrics to ensure that data quality standards are consistently met and improved upon. Show less Patient Medical Information Extraction:• Comprehensive extraction of all pertinent medical information from the patient's records.• Thorough review of all source documents to ensure accurate data collection.Medical Coding with MedDRA Terminology:• Precise coding of medical information utilizing the MedDRA terminology.• Technical Document Preparation:Technical preparation of documents in accordance with established procedures.• Validation and pre-assessment of the case documentation to meet required standards. Show less

  • Patient Safety Specialist +

    Sept 2021 - now

  • Patient Safety Associate

    Feb 2021 - Sept 2021

  • Medical Extractor

    Sept 2020 - Feb 2021