ABHISHEK SHUKLA

Intake Activity & Drug Safety Mail Handler:

• Primary role to perform overall intake activity and handling Drug safety mailbox. Periodic work allocation to the team in a maner to meet regulatory and partner compliance.
• Responsible to assign each emails received in drug safety mailbox and to send acknowledgement to partner/affiliated with details of our database case ID and other required details.
• Being a Drug safety mailbox handler responsible to send query/clarification to partner/affiliate for team. Archive emails of safety mailbox on sharepoint so that team can access.
• Tracking of work progress as per assignment and publish progress report with the managers to ensure smooth process flow and to achieve team utilization.
• Preparation and take care of various trackers (Daily intake, Master Intake and Compliance and ICSR trackers). To crosscheck and validate the entries in live trackers along tracker sanity on real time.
• Preparation of routine reports like Productivity and quality/Deficits/Hold cases/Reconciliation/Compliance and EOD inflow status to share with management and MIS with detailed breakups for better visibility.

SME:

• Quality trend analysis and discussion with team, To conduct refresher for team as per quality trend analysis .
• Being SME responsible to convey updates/changes discussed in client call, .
• To convey the team query to the client and partner.
• Required and to take clarification to resolving on realtime in ''Dedicated team helpdesk group''.

Quality Control:

• Perform QC and IQC activity for serious cases if needed.
• Provide feedback to concerned triager, data entry and QC and discus the correct approach and actual convention with examples to deliver defect free cases and to avoid any repetition of similar error.

Miscellaneous Activities:

• Perform Recon Activity for multiple tasks (Mailbox emails, Intake tracker, ICSR tracker, E2b reports).
• Team POC for multiple activity like leave management to maintain 10% leave quota for team and training completion status of team, Shift shuffling to maintains the role wise headcount to handle the inflow, weekend/holiday working team plan if needed.
• Perform testing on Database upgrade

• Database Experience: ARISG 6.5

Data Entry:

• Started with data entry of ICSRs into database, generated from different sources (post marketing survey, clinical trial, Regulatory authority, literature articles and spontaneous) following the guideline provided by client.
• Responsible for writing medically relevant narrative, MedDRA coding, Drug coding through CPD and WHO DD, and checking the completeness and accuracy of the data entered in the various fields.
• Assessing Follow-up activities and initiating as per requirement.

Quality Control:

• Quality review of the case processed by case processors and verify the medically relevant narrative, MedDRA coding, Drug coding through CPD and WHO DD, and to validate the completeness and accuracy of the data entered in the various fields vs source document.
• Provide the feedback to the data entry team members for the errors and suggest quality improvement ideas like checklist of critical fields, self QC of own cases, discussion of rare scenarios.
• Resolving problems and doubts of team by discussing multiple scenarios (common and exceptional scenarios) to deliver and maintain the individual quality and productivity numbers, for betterment of individual performance as well as teams performance. Also take initiative to get clarification on common doubts/query of team in client connects.

Miscellaneous Activities:

• Reconciliation activity for cases.
• Provide mentorship to new associates and supervise them for convention's and data entry points in order to meet the quality requirements.
• Being POC of the team responsible for multiple activities like collecting the details of any needfull data for team, sharing the routine emails in absence of Lead.

Case Processor:

• Identification of AEs, SAEs, Medication Errors, Product Complaints, Special Case Scenarios and working on them accordingly.
• Case processing of Solicited, Literature, Regulatory and Spontaneous ICSRs
• Completion of data into database from source documents including narrative (narrative writing), complete detailing the adverse events (MedDRA Coding), selection of adverse terms, concomitant medications and medical history against source documents.
• Follow-up with HCPs and reporters for more details related to ICSR.

Peer Reviewer:

• Verification of data entered in all the appropriate fields in accordance with company guidelines from source documents.
• Provide appropriate feedback to case processor in audit sheetFurther assessment on processed case to Identify any potential AEs, SAEs, Complaints or special scenarios and document our approach into contact log section for better understanding.

Quality-on-Quality Auditor:

• Perform random audits on the cases processed by the peer reviewer team to check the quality according to standard procedures.
• Conduct training sessions and refreshers for the team. Prepare the monthly quality review data to track and analyze the top defects of the team to identify the training needs.
• Team huddle to ensure that all the recent updates are shared with the team on a regular and timely basis and maintain process update repository.
• Create questionnaire for team calibration according to updates and error trend.

• Kept patient care protocols and clinical trial operations in compliance.
• Collected, processed and delivered specimens from trial participants.
• Took vital signs and collected medical histories as part of study protocols.
• Monitored subject enrollment and tracked dropout details.

• Practical exposure of drug manufacturing process for different different formulations like tablet, capsule, syrup etc.
• Storage and handling of raw material and finished product and their packaging.
• Documentations as per SOP and guidelines.
• Practical and live experience for different different equipments and machinery used in manufacturing process.