Professional Summary
Overview
Work History
Education
Skills
Timeline
Selected Career Highlights
Safety Systems & Tools

Sajitha Reema Fernandes

GlaxoSmithKline (GSK)
Bengaluru
17
Years of experience

Pharmacovigilance professional with 13+ years of experience driving global safety operations, operational excellence, quality governance, compliance, and business transformation initiatives across complex global organizations.

Recognized for leading cross-functional programs, improving operational effectiveness, influencing stakeholders without direct authority, and enabling successful adoption of new processes and technologies. Combines deep pharmacovigilance expertise with strategic thinking, change leadership, process optimization, and stakeholder engagement to deliver sustainable business outcomes.

Known for building trusted partnerships, identifying risks proactively, improving quality and compliance, and translating business needs into practical operational solutions. Experience includes safety operations, quality management, digital transformation initiatives, team development, process improvement, and global stakeholder collaboration.

Work History

Senior PV Operations Specialist I/Team Lead

5 Years 5 Months
GlaxoSmithKline (GSK) | 02.2021 - Current
  • Spearhead global pharmacovigilance transformation programs, driving adoption of digital, automated, and AI-enabled solutions that enhance operational scalability, compliance, quality, and user experience across the safety ecosystem.
  • Lead cross-functional initiatives spanning operations, quality, technology, and business functions to deliver sustainable process improvements, accelerate organizational change, and optimize end-to-end safety operations.
  • Influence strategic decision-making by providing expert guidance on operational risk, regulatory compliance, process governance, and business transformation priorities.
  • Build high-performing teams through coaching, capability development, knowledge sharing, and leadership of complex global initiatives within matrixed organizations.
  • Establish robust governance models, performance metrics, and vendor oversight frameworks that strengthen accountability, drive continuous improvement, and support inspection-ready operations.
  • Act as a trusted advisor to senior stakeholders by bridging business needs and technology capabilities, ensuring delivery of effective, scalable, and future-ready solutions.

Operations Specialist II

8 Years 1 Month
IQVIA (formerly Global PV Services) | 01.2013 - 02.2021
  • Managed end-to-end pharmacovigilance activities across clinical trial and post-marketing settings.
  • Acted as SME for outbound follow-up, pregnancy exposure case management, and development of targeted questionnaires, enhancing data accuracy.
  • Supported audits, inspections, and compliance reviews, ensuring regulatory adherence.
  • Designed and delivered training models, including interactive kinesthetic learning programs, to improve knowledge retention and engagement.
  • Key Achievements Developed targeted follow-up questionnaires improving pregnancy case data quality. Proposed and implemented solutions that shaped operational strategies and enhanced process efficiency.
  • Streamlined operational workflows to enhance efficiency and reduce processing times.
  • Developed training materials to support onboarding of new team members.

Customer Service Representative

2 Years
Accenture | 01.2010 - 01.2012
  • Provided customer service and resolved issues to enhance client experience.
  • Enhanced customer satisfaction by streamlining processes and managing escalations.
  • Resolved customer inquiries through effective communication and problem-solving techniques.
  • Enhanced customer satisfaction by delivering timely and accurate support solutions.

Education

Post Graduate Diploma - Clinical Research

Avigna Clinical Research Institute | Bengaluru, India | 01-2012

Bachelor of Science (B.Sc.) - Nursing

Government College of Nursing | Bengaluru | 01-2010

Skills

Safety operations
People development
Quality compliance
Business transformation
Stakeholder engagement
Operational improvement
Project planning
Interdepartmental communication
Cross-functional communication
Risk assessment
Analytics and Decision Making

Timeline

Senior PV Operations Specialist I/Team Lead

GlaxoSmithKline (GSK)
02.2021 - CurrentRead More

Operations Specialist II

IQVIA (formerly Global PV Services)
01.2013 - 02.2021Read More

Customer Service Representative

Accenture
01.2010 - 01.2012Read More

Government College of Nursing

Bachelor of Science (B.Sc.) from Nursing
Read More

Avigna Clinical Research Institute

Post Graduate Diploma from Clinical Research
Read More

Selected Career Highlights

  • Led global vendor transition ensuring uninterrupted regulatory compliance.
  • Supported digital transformation initiatives including automation, BOT processes, and Reportum optimization.
  • Recognized for risk identification and CAPA leadership during audits and inspections.
  • Built strong partnerships across operations, technology, quality, and vendors to deliver organizational objectives.
  • Recognized with AHEAD Together Awards (2022, 2025, 2024) for impactful contributions.

Safety Systems & Tools

Argus, ArisG, Reportum, Veeva, Sceptre, Power BI Dashboards, Alteryx

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Sajitha Reema Fernandes