Sreedevi Raveendran

• AI Requirements & Process Engineering: Elicited and translated complex clinical and regulatory needs into functional user stories for multi-agent LLM framework , engineering automated workflows to streamline protocol safety reviews and anticipate health authority queries.
• Strategic Leadership: Led cross-functional teams and collaborated with global stakeholders, developers, and vendor SMEs to architect innovative, scalable reporting solutions for Pharmacovigilance (PV).
• BI Transformation: Spearheaded transition from static, traditional reporting to interactive IBM Cognos and Tableau dashboards, significantly reducing data retrieval time and enhancing real-time decision-making.
• Regulatory Expansion: Directed integration of Medical Device reporting into BI ecosystem, ensuring compliance with evolving global safety regulations.
• Agile Collaboration: Facilitated requirement-gathering workshops with cross-functional teams to identify project risks and maintain prioritized, high-value product backlog.
• Compliance Expertise: Applied deep subject matter expertise to analyze and report safety data in strict accordance with GVP (Good Pharmacovigilance Practices) and global regulatory standards.
• Operational Excellence: Led end-to-end training and knowledge transfer for Operations teams during Hypercare and post-go-live phases to ensure system adoption and stability.

Achievements

• Engineered scalable reporting solution that replaced 1,800+ manual QTT reports with 8 self-service BI dashboards, empowering business groups with fully autonomous data management.
• Enabled Medical Device Periodic Reporting module, critical component in securing and maintaining Roche's status as Legal Manufacturer in EU market.
• Led seamless migration from legacy systems to modern, intuitive tools, maintaining business continuity during transition.

• Clinical Product Oversight: Oversaw customisation and global delivery of IRT (Interactive Response Technology) and eCOA (electronic Clinical Outcome Assessment) software, aligning technical solutions with stringent regulatory standards, and emerging market trends.
• Protocol Analysis: Conducted comprehensive analysis of clinical protocols to define complex business requirements, balancing stakeholder objectives, task complexity, and global regulatory guidelines.
• Technical Specifications: Translated high-level business needs into detailed functional and non-functional specifications, bridging gap between clinical requirements and IT development teams to ensure project alignment.
• Cross-Functional Integration: Orchestrated collaboration between regulatory, clinical, and technical departments to drive seamless integration and enterprise-wide adoption of clinical trial software.
• Bid Defense & Advocacy: Acted as Subject Matter Expert (SME) and Product Ambassador during high-stakes bid defenses, leading workshops and product demonstrations to secure stakeholder buy-in.
• Risk Management: Executed proactive risk assessments and mitigation strategies at study level, ensuring on-time delivery of eCOA and IRT capabilities while minimizing potential project delays.
• Strategic Acceleration: Developed and implemented optimized business process strategies to accelerate delivery of clinical solutions, specifically supporting high-priority COVID-19 drug trials.

Achievements

• Successfully delivered customized IRT and eCOA solutions that met regulatory requirements and addressed market demands, enhancing clinical trial efficiency.
• Played critical role in supporting COVID-19 drug trials by streamlining delivery of clinical trial solutions, contributing to faster time-to-market for life-saving treatments.
• Improved stakeholder satisfaction by effectively addressing functional and operational queries during bid defense activities, leading to increased client confidence and project wins.

• Test Automation & Efficiency: Identified key opportunities for automation within web service testing, developing custom scripts that reduced manual testing efforts by 40%.
• Data Integrity & Validation: Utilized SQL and advanced data-querying technologies to perform rigorous backend validation, ensuring 95% data accuracy for all automated test outputs.
• Agile Facilitation: Partnered closely with Scrum Master to drive Agile ceremonies, including sprint planning, retrospectives, and daily stand-ups, to maintain project momentum.
• Continuous Improvement: Documented critical insights and lessons learned across project lifecycle, translating feedback into actionable improvement plans for subsequent sprints.
• Quality Engineering: Leveraged automated verification techniques to eliminate data discrepancies, significantly increasing reliability of system-wide test results.
• Productivity Optimization: Enhanced team velocity and cross-functional collaboration by actively streamlining communication between development and QA workflows.

• Application Development: Developed and maintained robust web applications for global insurance clients, ensuring strict alignment with technical specifications provided by business analysts and architects.
• Workflow Optimization: Designed and implemented automated scripts to identify and resolve performance bottlenecks, significantly optimizing low-performing workflows and system efficiency.
• Project Delivery & Milestones: Partnered with project managers to establish and meet aggressive coding milestones, maintaining a 95% on-time delivery rate across two years of pre-release software cycles.
• Technical Excellence: Adhered to rigorous coding standards to deliver high-quality, scalable, and maintainable Java-based solutions, ensuring long-term system stability.
• Knowledge Management: Authored and maintained comprehensive technical documentation that accelerated developer onboarding and facilitated seamless knowledge transfer across cross-functional teams.