Summary
Overview
Work History
Education
Skills
Websites
Certification
Awards
Languages
Timeline
Generic
Sonam Mourya

Sonam Mourya

Bengaluru

Summary

Hi, I’m Sonam Mourya, a Principal Safety Operations Specialist with over a decade of experience in Safety and Pharmacovigilance. My expertise lies in optimizing processes to align seamlessly with Quality Management System requirements, enhancing compliance and operational efficiency.

While most Safety and Pharmacovigilance professionalsfocus on reactive compliance*, I specialize in leveraging AI-powered tools and data analytics to provide real-time, actionable insights that transform quality management. This approach empowers leadership with a centralized view of critical metrics, reducing inefficiencies and driving measurable impact.

🚀 The TransformationIn 2024, I faced the challenge of building trust in AI-powered dashboards, navigating data collation complexities, and overcoming my own limited experience with advanced Power BI tools. Recognizing the potential to streamline oversight, I developed interactive, data-driven Power BI dashboards that significantly reduced overdue records while cutting down Quality Issues (QI) CAPAs by 11% and Audit CAPAs by 58% (compared to 2023 data).

🏆 Methodology & Recognition

  • Designed a dynamic, one-page Power BI report enabling top-down exploration.
  • Created a detailed user guide for seamless adoption.
  • Mastered DAX and queries to drive insightful data representation.
  • Earned recognition in the Manager Recognition Program for Innovation, affirming the impact of my solutions.

💡 Vision for the Future Having worked at IQVIA and Syneos Health, I’ve had the opportunity to refine methodologies that integrate AI-powered analyticswith compliance excellence. These experiences have enabled me to drive global operational efficiencies, lead cross-functional teams, and implement data-driven strategies that enhance oversight and decision-making.

As a Certified Project Management Professional (PMP) and an active member of PMI, I continuously leverage structured project management methodologies to foster innovation and efficiency within Safety and Pharmacovigilance.

I look forward to continuing to drive innovation, bridging the gap between advanced technology and compliance excellence. My mission is to position myself as a thought leader, championing data-driven decision-making and innovative process optimization to empower industry professionals.

Overview

10
10
years of professional experience
1
1
Certification

Work History

Principal, Quality Management System

Syneos Health
Bangalore
11.2021 - Current
  • Focused on enhancing project compliance and quality metrics through Lean and Six Sigma methodologies.
  • Worked with cross-functional teams to achieve goals.
  • Developed Power-BI dashboard to visualize project data, driving insights for leadership decision-making.
  • Monitored quality plans to ensure adherence to standards, regulations, and process improvement opportunities.
  • Coordinated with project leads to refine quality analysis processes, enhancing effectiveness and efficiency.
  • Maximized customer satisfaction by leveraging effective communication and problem-solving skills.
  • Created Global Reporting Requirement Tracker for Regulatory Affairs team, improving oversight.
  • Enhanced audit readiness checklist in collaboration with key stakeholders to streamline compliance efforts.
  • Conducted trend analysis on non-compliances across projects, implementing improvements based on findings.
  • Utilized advanced technical skills and expertise to troubleshoot complex problems and implement solutions.
  • Updated and maintained databases with current information.

Senior Operations Specialist

IQVIA
Bangalore
01.2015 - 11.2021
  • Experienced working in safety database of Argus, ARISg7, and Sceptre.
  • Managed adverse event reports and ensuring compliance with regulatory requirements.
  • As a Subject Matter Expert (SME) in narrative writing, developed a comprehensive set of operational procedures.
  • Implemented the new procedures, resulting in a 30% reduction in errors within three months.

Education

M.pharma - Pharmacology

Guru Ghasidas Central University
Bilaspur, India
09.2012

Bachelor of Pharmacy -

Rungta College of Pharmaceutical science and Research
Bhilai, India
09.2008

Skills

  • Development of dashboard - Power BI
  • Automation/Workflows - Power Automate Desktop
  • Risk management
  • FMEA
  • Deep-Dive Analysis
  • Root Cause Corrective Action
  • Quality Assurance
  • Safety Management
  • LEAN initiatives
  • Quality control metrics
  • Process defects
  • Innovation management
  • Technology integrations
  • Group facilitation and presentations
  • Operations oversight
  • Relationship building and networking
  • Stakeholder management

Websites

Certification

  • Certified Project Management Professional (PMP), 3255814, 06/01/22 to 06/01/28
  • Course completion certificate on Lean Six Sigma Black Belt, 2022
  • Python for Machine Learning and Data Science Master Class, 2021
  • Tableau 2020 A-Z: Hands-On Tableau Training for Data Science, 2021
  • Statistics for Data Science and Business Analysis, 2021
  • Operational Excellence Work-Out and Kaizen Facilitator, 2020
  • Proficient in Microsoft Advanced Excel, Power BI, and SharePoint, 2020
  • Qualified the Graduate Pharmacy Aptitude Test (GPAT), 2012

Awards

  • Recognition in the Manager Recognition Program for Innovation, for centralized dashboard development for the PV department, Sep 2024
  • Appreciation Award, 05/01/23, for maintaining exceptional quality
  • SME badge, 06/01/19, for effectively resolving process-specific issues
  • Bravo Award, 05/01/18, for outstanding delivery and commitment to quality
  • Star of the Month, 01/01/17, for consistently delivering error-free results

Languages

  • English
  • Telugu
  • Hindi

Timeline

Principal, Quality Management System

Syneos Health
11.2021 - Current

Senior Operations Specialist

IQVIA
01.2015 - 11.2021

M.pharma - Pharmacology

Guru Ghasidas Central University

Bachelor of Pharmacy -

Rungta College of Pharmaceutical science and Research

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