Manasa Thamma
Hyderabad
Summary
Argus Safety Technology Analyst with nearly 6 years of pharmacovigilance experience, specializing in Oracle Argus Safety configuration, E2B reporting, and safety database management in a multi-client CRO environment. Skilled in Oracle Analytics reporting, system upgrades, validation, and SIS support, delivering compliant, high-quality PV technology solutions.
Overview
9
9
years of professional experience
Work History
Safety Technology Analyst
Parexel International
01.2023 - Current
- Extensive experience working in a CRO environment, supporting multiple global clients with diverse pharmacovigilance requirements, and business rules.
- Successfully handled multi-tenant Argus environments, configuring and maintaining separate client setups, including products, studies, workflows, and reporting structures.
- Collaborated closely with clients to gather requirements, perform gap analysis, and deliver tailored configuration solutions to meet evolving business and compliance needs.
- Supported client audits and regulatory inspections, providing configuration evidence, validation documents, and system traceability as required.
- Led end-to-end study configuration, including creation of products, licenses, studies, workflows, and reporting setups aligned with client and regulatory requirements.
- Configured and managed E2B reporting, including setup of reporting destinations, rules, gateways, and ESM configuration for compliant electronic submissions.
- Expertise in Aggregate and Periodic Report configuration, including CIOMS II, PSUR, PBRER, DSUR, and custom line listings, ensuring adherence to global regulatory standards.
- Developed and optimized multiple reports in Oracle Analytics reporting tool, including SAE Query Reports, reconciliation reports, case listings, and operational dashboards.
- Performed E2B profile configuration and XML data analysis, ensuring accurate mapping of data elements and successful health authority submissions.
- Configured Advanced Conditions, business rules, and field validations to improve data quality, enforce compliance, and streamline case processing workflows.
- Managed Common Profile Switches and system configurations, aligning system behavior with evolving business and regulatory requirements.
- Maintained and governed Common Baseline and configuration documentation, ensuring compliance, audit readiness, and traceability.
- Supported system upgrades, patches, and migrations, including execution of Installation Qualification (IQ), Operational Qualification (OQ), and validation activities.
- Provided L2/L3 support for Argus Safety users, resolving system issues, troubleshooting configuration defects, and ensuring minimal disruption to business operations.
- Collaborated with cross-functional teams including PV operations, IT, and regulatory stakeholders to deliver high-quality, compliant Argus configurations.
- Good understanding of Oracle Argus Safety schemas and the database structure
Medical IT Specialist (Argus Safety)
Parexel International
01.2021 - 12.2022
- Gained hands-on experience in Oracle Argus Safety configuration and support while working in a CRO environment supporting multiple global clients.
- Assisted in end-to-end Argus Safety study setup, including configuration of products, studies, licenses, and reporting components under senior guidance.
- Supported configuration of business rules, advanced conditions, and field-level validations to improve data quality and streamline case processing.
- Contributed to maintaining configuration documentation and baseline documents, ensuring audit readiness and traceability.
- Supported MedDRA upgrades, including execution of scripts and assisting in dictionary synchronization activities.
- Provided L1/L2 production support, resolving user queries and configuration-related issues within defined timelines.
- Assisted in user access management, issue tracking, and resolution, ensuring minimal disruption to safety case processing activities.
- Usage of SQL during the project for data analysis and error identification
- Configuration & Mapping of User defined fields based upon the customer need.
Medical IT Special (SIS)
Parexel International
07.2019 - 12.2020
- Supported Safety Information System (SIS) activities with a focus on investigator reporting, ensuring timely and accurate distribution of safety reports to clinical sites.
- Assisted in monitoring and tracking investigator reporting compliance, ensuring adherence to regulatory and study-specific timelines.
- Provided system and user support for SIS-related issues, including troubleshooting reporting errors and data discrepancies.
- Provide L3 support in assisting complex issues and assisting the L1/L2 groups with various application issues
- Coordinated with PV and clinical teams to ensure accurate data flow and report generation within the safety system.
Project Specialist
Parexel International
07.2017 - 05.2019
- Supported Pharmacovigilance (PV) operations team in day-to-day activities, ensuring smooth execution of case processing and reporting tasks.
- Created and maintained trackers, logs, and dashboards to monitor case volumes, submissions, and project deliverables.
- Coordinated with cross-functional teams to update progress reports and highlight risks or delays.
- Maintained accurate documentation and operational records to support audit readiness and compliance.
- Provided administrative and operational support to improve team efficiency and workflow management.
- Coordinated project timelines, ensuring alignment with client expectations and regulatory requirements.
- Developed comprehensive project plans, incorporating stakeholder feedback to enhance execution efficiency.
- Assisted in work allocation, follow-ups, and status reporting, ensuring adherence to timelines and SLAs.
Education
Bachelors of Technology - Information Technology
Jawaharlal Nehru Technological University
HyderabadSkills
- Oracle Argus Safety Configuration
- Argus Safety Administration
- Oracle Analytics Reporting
- Multi-client Environment Support
- Change Request Handling
- XML Data Review & E2B issues troubleshooting
- Requirement Gathering
- UAT Execution & Support
- Workflow Configuration & Case Processing Setup
- Aggregate Report Configuration (CIOMS II, Case Listings)
- Periodic Reporting (PSUR, PBRER, DSUR)
- Regulatory Reporting Setup
Timeline
Safety Technology Analyst
Parexel International
01.2023 - Current
Medical IT Specialist (Argus Safety)
Parexel International
01.2021 - 12.2022
Medical IT Special (SIS)
Parexel International
07.2019 - 12.2020
Project Specialist
Parexel International
07.2017 - 05.2019
Bachelors of Technology - Information Technology
Jawaharlal Nehru Technological University