JANARDHAN RAJ S

Key responsibilities:

• Perform initial evaluation of reported adverse events (serious and non-serious) from all sources.
  Perform case entry and verification of reported non-serious and serious adverse events; enter the reported information in the Novo Nordisk safety database – Argus, on the basis of individual case histories, correspondence with affiliates/sites and other departments in headquarters (HQ) and various administrative assignments.
• Ensure accurate and consistent coding of all events for serious and non-serious cases entered in the Argus with the use of (Medical Dictionary for Regulatory Activities).
• Evaluate causality, seriousness and listedness for all cases.
• Ensure that case narrative comprises correct and appropriate safety information.
• Ensure accurate and consistent coding of all events for serious and non-serious cases entered in the Argus with the use of (Medical Dictionary for Regulatory Activities).
• Evaluate causality, seriousness and listedness for all cases.

Additional Activities and Achievements:

• As a Team player have imparted the basic knowledge of Microsoft Excel and assisted the colleagues in team and other colleagues in the department when in need
• Handled buddy activity for some colleagues and guided them in all
  aspects of work and proficiency.
• Handled SOSPON Mailbox and maintained the timelines and a well established process environment and behavior with the stake holders and Affiliates.
• Shared Ideas about the automation of Automation of the triage Scripts process to reduce the time consumed and also provided the idea for automation of Verification Forms with argus to impart more quality of data processed. Both the ideas have been considered for implementation
• As a key member in the second phase of development of BOTArgus project i have applied my my knowledge and skills for further development of the new checks.
• Involved in the development of Argus Optimize project and provided ideas and knowledge in development of the project
• Reconciliation of the Deleted cases from post marketed teams and imparted the knowledge of good deletion comments which further decreased the number of cases being deleted due to Improper Triage .
• Involved in SOP Review as core member in review of changes.
• Involved as a team member of TGA PV Inspection and assisted in the activities requiring my role.
• Was part of MHRA-GCP PV inspection and assisted in activities requiring my role.
• As a part of the Feedback group conducted some activities along with the team to impart the Feedback culture among the employees and also shared knowledge on the development of the Digital Feedback process.
• Presently handling the role of EDC super user

Key responsibilities:

• Perform initial evaluation of reported adverse events (serious and nonserious) from all sources.
• Perform case entry and verification of reported non-serious and serious adverse events; enter the reported information in the Novo Nordisk safety database – Argus, on the basis of individual case histories, correspondence with affiliates/sites and other departments in headquarters (HQ) and various administrative assignments.
• Ensure accurate and consistent coding of all events entered in the Argus with the use of (Medical Dictionary for Regulatory Activities).
• Evaluate causality, seriousness and listedness for all cases.
• Ensure that case narrative comprises correct and appropriate safety information.
• Assess the need for follow-up information and issue follow-up requests for all cases and post queries in EDC and/or to affiliate.
• Maintain work within strict timelines

Achievements and additional activities:

• Handled buddy activity for some colleagues and guided them in all
  aspects of work and proficiency.
• Involved in BOTArgus optimization project and i have provided inputs for new field checks and in updating of the existing checks. Received a good applause from the stake holders for the excellent work.
• Involved in SOP Review as core member in review of changes.
• Review of KPI reconciliation.
• Keeping a vigil on maintaining timelines in case of action items.
• Involved in case and database clean-up activities.

Key Responsibilities:

• Receive, triage, review and process data from various sources on time, within budget and meet quality standards.
• Allocation of work to the colleagues.
• Safety Data review involving Discrepancy Management using RAVE and INFORM platforms.
• Performance of all patient data management tasks including Intake,
  Triage, Case Processing, Discrepancy Management, Query Generation, Report and Listing Generation, data reconciliation.
• Perform basic quality control procedures with guidance from Functional Manager.

Additional activities:

• Preparation of Query Management reports on monthly basis.
• Identify and report protocol deviations.
• Safety Management Plan Review as per the deviations to support
  safety.
• SME (Subject Matter Expert) for several protocols
• Worked in different clinical trial projects because of best quality
• Simplification of quality control process.

Awards & Honors:

• Leading performance recognition award by the manager

Key Responsibilities:

• Receive, triage, review and process data from various sources on time, within budget and meet quality standards.
• Performance of all patient data management tasks including Intake,
  Triage, Case Processing, Discrepancy Management, Query Generation, Report and Listing Generation, data reconciliation.

Awards & Honors:

• Applause Award for Team Player from Manager