Vignesh Rajaram

• Manages all activities to be carried out according to the current SOW.
• Acts as a management level liaison between GEHC, Qinecsa managements, and the project delivery team.
• Ensure that project team members are appropriately trained on all project SOPs, guidelines and documents as required.
• Ensures appropriate and adequate resource allocation and back-up roles for project continuity, timely delivery as well as projected increases in workload.
• Recruitment, selection, training of team members and managing attrition when required.
• Quality and timely delivery through a rigorous metrics-based approach.
• Acts as guide, coach, and counsellor to the team.
• Ensuring team’s performance in terms of compliance with SLAs.
• Leave Management of the team.

• Leading client calls and tracking client communication on regular basis regarding operational deliverables.
• Ensuring team’s performance in-line with compliance and SLA's.
• Record, maintain and track the metrics for both team members and project performance.
• Responsible to mentor the trainees on the job and ensure they reach the required efficiency & accuracy levels in data entry.
• Ensure appropriate distribution of work among direct reports.
• Responsible for day-to-day work, process flows and constantly endeavoring to be able to lead the team from the front.
• Reporting to the operations manager on performance, status, and any escalations.
• Capture quality data for metrics reporting.
• Ensure the completeness and accuracy of the source documents provided by the client for ICSR/ CO preparation.
• Schedule meetings with client SPOC to resolve report related queries.
• Ensure all the records and documents are maintained as per organizational requirements.
• Attend training sessions and develop capabilities on an ongoing basis.
• Delegate tasks and responsibilities to appropriate personnel.
• Preparing CAPA & RCA for overall projects.
• Performance & people management.

• Ensuring team’s performance in-line with compliance and SLA's
• Responsible to mentor the trainees on the job and ensure they reach the required efficiency & accuracy levels in data entry
• Ensure appropriate distribution of work among direct reports
• Responsible for day-to-day work, process flows and constantly endeavoring to be able to lead the team from the front
• Reporting to the operations manager on performance, status and any escalations
• Capture quality data for metrics reporting
• Ensure the completeness and accuracy of the source documents provided by the client for ICSR/ CO preparation
• Schedule meetings with client SPOC to resolve report related queries
• Ensure all the records and documents are maintained as per organizational requirements
• Attend training sessions and develop capabilities on an ongoing basis
• Preparing CAPA & RCA for overall projects
  12. Performance & people management

Key responsibilities as Case Processor (ICSR):

• Case book-in, triage, data entry, coding using Meddra and summary writing for ICSRs, labeling, Peer Review, Perform any other support activities as assigned – tracking various types of information and metrics, ongoing QC of defined process steps
• Performed quality check of cases based on priority of regulatory submission
• Take responsibility of the corrective actions resulting from timelines or quality issue
• Confirm the case validity, seriousness, event term selection, coding of adverse events, suspect products, concomitant medications, lab investigations and overall consistency of information
• Determines whether the follow up information is medically significant or relevant and takes necessary actions
• Develop and maintain expertise and knowledge of all assigned products within a therapeutic areas applicable corporate and global regulations, guidelines, Standard Operation procedure and writing practices

Key responsibilities as Case Book in Associate and QC Associate (CO Specific):

• Receipt / download of cases from Document Exchange Tool and allocate to associates.
• Triage of cases for validity and seriousness.
• Perform Duplicate Search. Book-in Initial (new) case / Follow up to existing referenced case (LAM) depending upon the duplicate search results.
• Data entry of mandatory information into Argus Affiliate (AA). Self / Peer QC of the cases before routing to central processing (As applicable).
• Complete the daily case tracking spreadsheet with LAM IDs.
• Handling of queries (action items) received from the central processing sites regarding discrepancies in Source Documents, AE form and / or Argus affiliate.
• Confirming all the data are maintained according to the requirements of the SOPs.
• Preparing CAPA & RCA for TAT miss and external quality findings.
• Ensuring team’s performance is in-line with compliance and SLAs

Key responsibilities as Case Processor (ICSR):

• Case book-in, triage, data entry, coding using Meddra and summary writing for ICSRs, labeling, Peer Review, Perform any other support activities as assigned – tracking various types of information and metrics, ongoing QC of defined process steps
• Performed quality check of cases based on priority of regulatory submission
• Take responsibility of the corrective actions resulting from timelines or quality issue
• Confirm the case validity, seriousness, event term selection, coding of adverse events, suspect products, concomitant medications, lab investigations and overall consistency of information
• Determines whether the follow up information is medically significant or relevant and takes necessary actions
• Develop and maintain expertise and knowledge of all assigned products within a therapeutic areas applicable corporate and global regulations, guidelines, Standard Operation procedure and writing practices

• Involving in the Method development, validation and analysis of study samples. Preparation and planning for clinical trials, internal audits and external audits. Extraction of active analyte from the biological samples and prepares a sample suitable for the mass spectrometric analysis. Monitoring the analytical run and report to the group leader. Drug and biological sample accountability, Coordination in investigational site. Preparation of SOP’s and other works assigned by the group leader. Calibration of analytical instruments and Maintaining records. Literature survey of the molecules intended for an analysis. Preparation of Bio-samples.

• Involving in the Method development, validation and analysis of study samples. Preparation and planning for clinical trials, internal audits and external audits. Extraction of active analyte from the biological samples and prepares a sample suitable for the mass spectrometric analysis. Monitoring the analytical run and report to the group leader. Drug and biological sample accountability, Coordination in investigational site. Preparation of SOP’s and other works assigned by the group leader. Calibration of analytical instruments and Maintaining records. Literature survey of the molecules intended for an analysis. Preparation of Bio-samples.