Shashank Dubal

• Responsibilities:
• Providing support for other activities undertaken by the project team on behalf of the client and the company.
  Performing activities within the scope of the ICSR management unit, within an agreed extent and timeframe (including, but not limited to):
• Processing Individual Case Safety Reports (ICSRs) from all sources in compliance with applicable regulations, PrimeVigilance procedures, and in accordance with client-specific requirements and timelines, performing ICSR follow-up.
• SAE/SUSAR Management (clinical trial reconciliation, protocol review, Safety Management Plan review), reconciliation (clinical, partners), personal data protection.
• Product quality, complaint handling, and interaction with quality assurance.
• Medical information interaction, MedDRA, and WHO coding.
• Support of PV processes related to ICSR management within PrimeVigilance and to clients.
• Performing activities within the scope of the ICSR management unit, within the agreed extent and timeframe.
• Perform team lead activities.

Responsibilities

• Developing, designing, configuring, and rolling out new application modules, workflows, and catalog requests.
• Writing business rules, client scripts, UI actions, and UI policies as per the client requirement.
• Implementation of Problem Management, Incident Management, Change Management, Service Catalog Management, and Email Notifications.
• Involved in developing workflows. Development of SLA for the organizations. Implementation of ACL, Customized Service Catalog Management.
• Performed code migration using Update Sets. Used web services, email integration, to integrate applications and data sources.
• Developed import sets to import data from different sources.
• Developed transform maps to map values between import sets and ServiceNow tables.
• Involved in developing transform scripts to trigger events during the import process.
• Creation of email notifications and inbound actions. Customizations migration between instances using update set.
• As per the best practices of ServiceNow, developed and configured Business Rules, Script Includes, UI Policies, and Client Scripts.
• Developed and maintained APIs and data integration processes between ServiceNow and other services.
• Used SOAP and REST web services for integrating different instances.

• Responsibilities
• Developing, designing, configuring, and rolling out new application modules, workflows, and catalog requests.
• Writing business rules, client scripts, UI actions, and UI policies as per the client requirement.
• Implementation of Problem Management, Incident Management, Change Management, Service Catalog Management, and Email Notifications.
• I was involved in developing workflows. Development of SLA for the organizations. Implementation of ACL, Customized Service Catalog Management.
• Performed code migration using Update Sets. Used web services, email integration, to integrate applications and data sources.
• Developed import sets to import data from different sources.
• Developed transform maps to map values between import sets and ServiceNow tables.
• I was involved in developing transform scripts to trigger events during the import process.
• Creation of email notifications and inbound actions. Customizations migration between instances using update set.
• As per the best practices of ServiceNow, developed and configured Business Rules, Script Includes, UI Policies, and Client Scripts.
• Developed and maintained APIs and data integration processes between ServiceNow and other services.
• Used SOAP and REST web services for integrating different instances.

Responsibilities:

• Review Adverse Event (AE) report data for completeness, and verify certain fields to determine if they are critical (including, but not limited to, reportability) as well as conformity to E2B standards.
• Initiate follow-up activities to obtain additional information and clarification, as appropriate.
• Forward cases for case review, or invalid workflow, in the global safety database.
• Peer reviews the cases and evaluates for accuracy, consistency, and completeness in the safety database against the source document. This includes, but is not limited to, checking the consistency of the narrative and other data fields, ensuring that the main reason for any delay is entered in the routing comment as appropriate.
• Correct the data entry errors, if any, prior to routing the case in the global safety database.
• Track and document all observations and recommendations on the defect tracker. Review data entered in the safety database for completeness and accuracy, with reference to source documents, as per applicable SOPs, work instructions, and client guidelines.
• Train the data entry team in order to ensure the highest quality.
• Provide feedback to the data entry team members for the errors noted, and assist in the overall quality improvement of the process.

• Responsibilities:
• Confirms case validity.
• Correct the data entry errors, if any, prior to routing the case in the global safety database.
• Review and evaluate AE case information to determine the required action based on and following internal policies and procedures.
• Process all incoming cases in order to meet timelines.
• Enter and code, as applicable, case data, including, but not limited to, event, seriousness, reported causality (when appropriate), medical history, and laboratory data, as provided by the reporter.
• Code products specified as suspect or concomitant by the reporter.
• Provide the narrative, as required.
• Review Adverse Event (AE) report data for completeness, and verify certain file IDs to determine if they are critical (including, but not limited to, reportability) as well as conformity to E2B standards.
• Initiate follow-up activities to obtain additional information and clarification, as appropriate.
• Forward cases for case review or invalid workflow in the global safety database.
• Peer reviews the cases and evaluates for accuracy, consistency, and completeness in the.
• Safety database against the source document. This includes, but is not limited to, checking the consistency of the narrative and other data fields, ensuring that the main reason for any delay is entered in the routing comment as appropriate.
• Confirms event term selection and coding.
• Confirms/assesses the event's seriousness.
• Performs listedness assessment.
• Initiate the SUSAR process by notifying Pfizer and routing the case back to Pfizer for processing.
• Determine whether additional queries through the DSU are needed at this stage, and document them in the global safety database with a brief description of the information needed.
• Identify spontaneous cases that are a result of stimulated reporting by adding the appropriate case classification.
• Track and document all observations and recommendations on the defect tracker.