Paul joshisree kopperla

I am a highly logical and meticulous professional with nearly eight years of experience in drug safety data analytics and reporting. My approach is rooted in strict adherence to compliance and a pragmatic drive for organized, diligent execution, ensuring accuracy and reliability in all outcomes.

Experience

Drug Safety Associate_Data Analytics & Reporting

Qinecsa Solutions · Apr 2024 – Present

Not yet confirmed

• Pharmacovigilance Responsibilities:
•  Process Individual Case Safety Reports (ICSRs) in accordance with global regulatory guidelines.
•  Perform case assessment, quality review, and MedDRA coding.
•  Review literature, spontaneous, and clinical trial safety cases.
•  Ensure compliance with regulatory timelines and internal SOPs.
• Data Analytics & Reporting Responsibilities:
•  Analyzed healthcare and pharmacovigilance datasets to identify trends, quality metrics, and operational insights.  Created weekly and monthly productivity reports using Advanced Excel.
•  Built interactive dashboards using Pivot Tables, Pivot Charts, and Power Query.
•  Performed data cleaning, validation, and reconciliation to improve reporting accuracy.
•  Tracked key performance indicators (KPIs) including case volume, turnaround time, and quality metrics.
•  Automated recurring reports, reducing manual reporting effort.
•  Collaborated with cross-functional teams to support data-driven operational decisions.
•  Conducted root cause analysis to identify workflow bottlenecks and recommend process improvements.

Drug Safety Associate

Qinecsa Solutions · May 2021 – Present

Not yet confirmed

• Analyzed healthcare and pharmacovigilance datasets to identify trends, operational insights, and business performance metrics, enabling data-driven decision-making.
• Demonstrated experience collecting, consolidating, cleaning, validating, reconciling, analyzing, and presenting operational data from approved source systems and business trackers to support project oversight and operational decision-making.
• Developed interactive dashboards and automated reports using Advanced Excel, Pivot Tables, Pivot Charts, and Power Query to monitor productivity, turnaround time (TAT), quality metrics, and key performance indicators (KPIs).
• Designed and maintained weekly, monthly, and ad hoc MIS reports and executive dashboards to monitor operational performance and business outcomes.
• Conducted trend analysis, variance analysis, and root cause analysis to identify workflow bottlenecks, improve reporting accuracy, and recommend process improvements.
• Automated recurring reporting processes using Advanced Excel and Power Query, reducing manual effort and improving reporting efficiency.
• Collaborated with cross-functional teams and stakeholders to gather reporting requirements, analyze business data, and deliver actionable insights through data visualization and reporting.
• Prepared executive-ready reports and presentations to support operational planning, business reviews, and continuous improvement initiatives while ensuring data accuracy and integrity.
• Processed Individual Case Safety Reports (ICSRs) from spontaneous, literature, business partner, and clinical trial sources in accordance with global regulatory guidelines, client requirements, and internal SOPs.
• Reviewed and assessed clinical trial safety cases using supporting documents received through the Electronic Data Capture (EDC) system, ensuring complete and accurate safety data for case processing.
• Worked extensively with ARISg LSMV for case processing, workflow management, case lifecycle tracking, and quality review activities.
• Utilized Veeva Vault to access, review, and manage clinical trial and safety-related documents supporting pharmacovigilance operations.
• Performed MedDRA coding, case assessment, data validation, reconciliation, and quality review to ensure high-quality safety data and regulatory compliance.
• Validated and reconciled information across EDC documents, ARISg LSMV, Veeva Vault, and source documents to ensure case completeness, consistency, and data quality.
• Reviewed spontaneous, literature, and clinical trial safety cases within regulatory timelines while maintaining high standards of quality, compliance, and documentation.
• Collaborated with cross-functional teams to resolve data discrepancies, support case processing activities, and ensure timely completion of safety deliverables.

S

Data Analyst Intern

Sysslan IT Solutions · Jan 2026 – Apr 2026

Not yet confirmed

• Performed comprehensive train schedule data analysis using Python, Pandas, and Matplotlib to identify route patterns, journey durations, and station traffic trends.
• Cleaned, processed, and validated large railway datasets through data preprocessing and quality checks.
• Developed visualizations and analytical reports using pivot tables, cross-tabulations, and comparative charts.
• Built an interactive Train Route Enquiry System to display direct trains and estimated journey duration between stations.
• Conducted exploratory and advanced data analysis to generate operational insights and improve data interpretation.

Drug Safety Associate

Bioclinica · May 2021 – Apr 2024

Not yet confirmed

• Process 500+ Individual Case Safety Reports (ICSRs) every month while maintaining 99% on-time regulatory submissions.
•  Perform end-to-end case processing including intake, triage, validation, duplicate detection, data entry, medical review support, coding, quality review, and case closure.
•  Handle spontaneous, literature, pregnancy, mother–baby, clinical trial, health authority, legal, and business partner safety cases.
•  Perform medical coding using MedDRA, WHO Drug Dictionary, and company dictionaries.
•  Prepare medically accurate safety narratives ensuring data consistency and regulatory compliance.
•  Support FDA, EMA, and MHRA reporting using EVWEB and E2B(R3).  Conduct quality control reviews, reconciliation activities, and follow-up management to improve data accuracy.
•  Resolve safety queries through collaboration with global stakeholders and investigative sites.
•  Mentor junior associates on ICSR processing, medical coding, and quality standards.
•  Ensure compliance with SOPs, GVP, GCP, client SLAs, and global pharmacovigilance
• regulations.

G

Clinical Assistant

GNR Hospital · Jan 2019 – Dec 2020

Not yet confirmed

• Collected and analyzed 500+ patient records weekly, supporting clinical decision-making and treatment optimization.
• Monitored adverse drug reactions and medication errors, contributing to a 15% improvement in patient safety outcomes.
• Maintained structured and standardized clinical datasets, enhancing data accessibility and improving reporting efficiency.

What drives their work

The Architect

You build robust data structures that transform complexity into clarity.

Paul's superpower

You excel at transforming raw, complex data into dependable, actionable insights and interactive systems.

How Paul works

You are best suited for teams that value meticulous data integrity and leverage data to drive operational efficiency and strategic decisions.