Pranay Kumar Boddu

Workflow and Team Management:

• Directed daily deliverable management, enhancing resource utilization efficiency.
• Managed real-time monitoring of key deliverables to ensure prompt updates.
• Fostered continuous client communication to address requests promptly.
• Performed daily reconciliation of work inflow and outflow, ensuring transparent status updates to stakeholders.
• Ensured timely completion of training plans for direct and indirect reportees, monitoring, and documenting daily productivity and quality metrics for direct reportees.
• Oversaw team leave and overtime schedules to ensure balanced workloads.
• Monitored team performance for SLA compliance, ensured timely feedback to reportees and facilitated discussions on growth plans.
• Resolved team concerns and disputes while ensuring detailed documentation for BCP purposes.
• Working as SME:
• Trained new joiners for upcoming responsibilities.
• Performed quality assessments for diverse case types such as Spontaneous, Patient Support, Literature, CT cases, and Regulatory Authority reviews.

Quality Management:

• Performed weekly sample quality control analysis, calculated KPIs, and shared insights with team members.
• Conducted Root Cause Analysis for sample QC errors, communicating findings to managers and associates.
• Reviewed and updated quality documents based on client feedback.
• Facilitated internal audits with thorough preparation.
• Delivered consistent status updates to all team members and stakeholders.
• Consistently communicated with clients to address requests promptly.
• Conducted daily reconciliation of work inflow and outflow, providing transparent status updates to stakeholders.
• Ensured timely completion of training plans for direct and indirect reportees, monitoring and documenting daily productivity and quality metrics for direct reportees.
• Managed leave and overtime, promoting a healthy work-life balance within the team.
• Monitored team performance in terms of compliance with SLAs, providing timely feedback to reportees and discussing growth plans accordingly.
• Proactively addressed team concerns and conflicts, maintaining comprehensive records for Business Continuity Planning (BCP) purposes.
• Working as SME:
• Prepared new joiners for future responsibilities, providing knowledge support and handling team queries.
• Conducted quality checks for all types of cases, including Spontaneous, Patient Support, Literature, CT cases, and Regulatory Authority cases.
• Quality Management:
• Conducted weekly sample QC analysis, calculating KPIs and circulating details with the team.
• Performed Root Cause Analysis (RCA) for sample QC errors, discussing findings with managers and associates.
• Prepared and reviewed various quality documents based on client feedback, monitored the effectiveness of implemented action plans, and managed Corrective and Preventive Actions (CAPA) and deviations.
• Prepared for and facilitated internal and external audits.

As Case Intake Member:

• Responsible for Email intake, case intake, duplicate check, and registration of the case into the safety database.
• Maintain log of source documents and other communications
• Determine the validity of the case and complete the triage process

As Case Processor:

• Responsible for data entry of Individual case safety reports into the safety database.
• Review and evaluate AE case information to determine validity of a case, seriousness and expeditedness as per client and internal policies and procedures
• Process all incoming cases in order to meet timelines.
• Full data entry including medical coding and safety narrative.

As Medical Coder:

• Responsible for coding all medical history, events, drugs /procedures/indications and laboratory tests according to the appropriate dictionary (For e.g. MedDRA, Company Product Dictionary, DRL code).

As Narrative Writer:

• Responsible for writing medically relevant safety narrative of cases and checking the completeness and accuracy of the data entered in the various fields.

As Quality Reviewer:

• Review data entered in safety database for completeness and accuracy with reference to source documents as per applicable SOPs, work instructions and client guidelines
• Train data entry team in order to ensure highest quality.
• Provide the feedback to the data entry team members for the errors noted and assist in overall quality improvement of the process.

Triage:

• Responsible for Email intake, case intake, duplicate check, and registration of the case into the safety database.
• Maintain log of source documents and other communications
• Determine the validity of the case and complete the triage process
• Responsible for coding all medical history, events, drugs /procedures/indications and laboratory tests according to the appropriate dictionary (For e.g. MedDRA, Company Product Dictionary, DRL code).

• Oversee workflow management, actively involved in work allocation and ensuring timely completion of Individual Case Safety Report (ICSR) reporting within defined timelines.
• Collaborate with leads to analyze process deviations, including quality concerns, sample QC issues, and regulatory misses, preparing Root Cause Analysis (RCA) and Corrective and Preventive Actions (CAPA) as needed.
• Provide constructive feedback and updates to associates not meeting requirements, fostering continuous improvement.
• Participate in Quality Control Training Course (QCTC) weekly calls or meetings, sharing refresher trainings and client updates with the process team.
• Conduct regular reviews of case quality, prioritizing cases in accordance with safety data guidelines and maintaining quality scores above target levels.
• Take proactive initiatives to uphold project quality standards, identifying and addressing any training gaps within the team.
• Facilitate the creation and maintenance of training records for the team, ensuring ongoing competence and compliance with industry standards.
• Monitor adherence to current processing conventions and safety data guidelines, implementing necessary adjustments to optimize quality and efficiency.
• Actively participate in any additional quality assurance initiatives or projects aimed at enhancing overall process effectiveness and compliance.