SAFe Certified Product Owner/Product Manager with 14 years in IT, specializing in healthcare. Worked across Pharmacovigilance and Clinical trial systems as a Product owner and Business analyst. Known for excellent communication and delivering high-quality solutions and eager to learn new technologies and models.
Overview
15
15
years of professional experience
1
1
Certification
Work History
Sr. Product Owner – Pharmacovigilance Reporting
Roche
08.2021 - Current
Lead multiple teams across multiple vendors and worked closely with business stakeholders, developers, and vendor SMEs to design and develop innovative reporting and analytics solutions tailored to pharmacovigilance needs.
Played a pivotal role in the transformation journey by managing the product backlog, prioritizing user stories, and aligning deliverables with sprint goals, in collaboration with the Product Management team.
Collaborated and acted as the primary point of contact for vendors, ensuring the timely delivery of high-quality solutions, and seamless integration into the existing system.
Conducted workshops and stakeholder meetings to gather requirements, define user stories, and ensure alignment with business objectives.
Collaborated closely with the SAT, UAT, and Quality Management teams to ensure the validation process was aligned with the organizational quality standards and ensured the overall quality of the delivered product.
Championed user adoption by providing training, documentation, and ongoing support to business groups, ensuring a smooth transition to the new self-managed reporting tools.
Monitored and analyzed system performance, gathering user feedback to drive continuous improvement, and enhance the overall user experience.
Contributed to the strategic roadmap for the Reporting and Analytics module, ensuring alignment with organizational goals and regulatory requirements in pharmacovigilance.
Supported the Operations team by providing training on the new systems and equipping the team in triaging issues during hyper-care periods and the operational phase.
Achievements
Delivered a scalable and efficient reporting solution for PV systems by successfully replacing over 1,800 manual QTT reports with 8 user-configurable BI dashboards and line listings, enabling fully self-managed reporting by business groups.
Incorporated a new module for medical devices reporting to the PV platform provided by ARIS Global.
Successfully facilitated the transition from legacy systems to modern, user-friendly tools, ensuring minimal disruption to business operations.
Senior Business Analyst – Clinical Trial Assistance Software Solutions
Signant Health Ltd
12.2015 - 08.2021
Oversaw the customization and delivery of multiple clinical trial assistance software products, including Interactive Response Technology (IRT) and electronic Clinical Outcome Assessment (eCOA), by identifying regulatory requirements and aligning solutions with market trends.
Conducted in-depth analysis of stakeholder objectives by studying Clinical protocols and performed investigative work to define business requirements, considering task complexity, stakeholder needs, and regulatory guidelines
Translated business requirements into clear and comprehensive functional and non-functional specifications for the IT functional team, ensuring alignment with project goals.
Collaborated with cross-functional teams, including regulatory, clinical, and technical stakeholders, to ensure seamless integration and adoption of software solutions.
Acted as a product ambassador for IRT and eCOA solutions during bid defense activities, leading workshops, conducting product demonstrations, and addressing functional and operational queries from stakeholders.
Performed risk assessments and implemented mitigation strategies to ensure the timely delivery of eCOA and IRT capabilities at the study level, minimizing project delays and risks.
Developed and implemented innovative business process strategies to accelerate the delivery of clinical trial solutions, particularly during the critical COVID-19 drug trial phase.
Achievements
Successfully delivered customized IRT and eCOA solutions that met regulatory requirements and addressed market demands, enhancing clinical trial efficiency.
Played a critical role in supporting COVID-19 drug trials by streamlining the 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.
Program Analyst
British Airways
06.2013 - 12.2013
Identified opportunities to automate web service testing, and developed scripts to reduce manual testing efforts.
Utilized SQL and data-querying technologies to validate the correctness of data processed by automated test scripts.
Collaborated closely with the Scrum Master to facilitate Agile rituals, including sprint planning, retrospectives, and daily stand-ups.
Documented key insights and lessons learned throughout each project lifecycle, creating actionable plans to incorporate feedback into future sprints.
Achievements
Reduced manual testing efforts by 40% through the development and implementation of automated test scripts for web services.
Achieved 100% data accuracy in test results by leveraging SQL to validate and verify automated test outputs.
Enhanced team collaboration and productivity by actively participating in and supporting Agile rituals, and continuous improvement initiatives.
Web Developer (Java) – Insurance Products
Cognizant Technology Solutions
09.2009 - 05.2013
Developed and maintained web applications for insurance clients, ensuring alignment with specifications provided by business analysts and solution architects.
Designed and implemented automated scripts to identify and optimize low-performing workflows.
Collaborated closely with project managers to establish and achieve ambitious coding milestones for pre-release software projects.
Adhered to strict coding standards to deliver high-quality, maintainable, and scalable code.
Created and maintained clear, concise documentation to facilitate knowledge transfer, and ensure ease of understanding for team members.
Continuously updated skills and knowledge by staying current with the latest Java technologies and industry best practices.
Achievements
Decreased onboarding time for new developers through the creation of clear, comprehensive documentation.
Achieved a 95% on-time delivery rate over two years by effectively collaborating with cross-functional teams.
Earned professional certifications in the Java framework and domain certification in Insurance as part of a commitment to continuous learning and skill development.
Education
Bachelor Of Technology - Instrumentation And Control Engineering
Calicut University
Kerala, India
08.2008
Skills
Business Analysis
Product Backlog Management
Design thinking
Business Intelligence
User story creation
Artificial Intelligence (AI)
Presentation
Agile frameworks
Risk assessments
Certification
SAFe 6 Product Owner/Product Manager
Project Management: Healthcare Projects (2016)
IIBA Business Analysis Foundations: Business Process Modeling
Oracle certified Java Programmer
Timeline
Sr. Product Owner – Pharmacovigilance Reporting
Roche
08.2021 - Current
Senior Business Analyst – Clinical Trial Assistance Software Solutions
Signant Health Ltd
12.2015 - 08.2021
Program Analyst
British Airways
06.2013 - 12.2013
Web Developer (Java) – Insurance Products
Cognizant Technology Solutions
09.2009 - 05.2013
SAFe 6 Product Owner/Product Manager
Project Management: Healthcare Projects (2016)
IIBA Business Analysis Foundations: Business Process Modeling
Oracle certified Java Programmer
Bachelor Of Technology - Instrumentation And Control Engineering
Calicut University
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