Sandheep Balagoni

Accomplished Pharmacovigilance Specialist with over 9 years of progressive experience in end-to-end case management, quality review, and regulatory compliance. Expert in Argus Safety and ICSR processing for clinical and post-marketing cases under FDA, EMA, and ICH-GCP guidelines. Recognized for leadership, mentoring, and implementing process improvements that enhance data quality, operational efficiency, and compliance outcomes.

• End-to-End ICSR Case Management
• Pharmacovigilance Operations & Quality Review
• Project Management & Regulatory Compliance
• Data Analysis & Metrics Reporting
• Cross-functional Team Collaboration
• Risk Assessment and Mitigation
• Process Improvement & Root Cause Analysis
• CAPA Implementation & Audit Readiness
• ICH-GCP, ICH-E2A/E2B/E2C guidelines
• FDA, EMA, MHRA, Global regulatory reporting
• Literature, Clinical trial/SUSAR, Pregnancy, Child/foetus, vaccine and E2B cases.
• MedDRA, ICD and WHO disctionaries

• Having an overall 9 years of work experience in pharmacovigilance as a Case Processor, Peer Reviewer, Quality Reviewer, Subject Matter Expert and back-up team lead activities.
• Oversaw quality control and compliance for the processing of Individual Case Safety Reports (ICSRs) for both clinical trial and post-market cases, ensuring adherence to regulatory standards and best practices.
• Supervised the management of ICSR quality metrics to ensure full compliance with regulatory authority requirements and industry standards.
• Trained and onboarded new team members, ensuring alignment with project requirements and organizational standards.
• Analyzed and communicated case quality control results, providing insights and recommendations for process improvements.
• Led the implementation of corrective actions for case-related quality issues identified by associates, ensuring continuous improvement and compliance with standards.
• Provided audit and inspection support for case management activities, ensuring compliance and addressing requirements as needed.
• Performed additional duties as required by standard operating procedures or assigned by the supervisor, supporting team objectives and operational efficiency.
• Managed the growth and development of associates, providing mentorship, training, and performance feedback to support career progression and team success.
• Conducted weekly and monthly reviews of performance metrics (quality, volume, turnaround times) in alignment with contractual agreements to ensure compliance and operational efficiency.
• Provided subject matter expertise in interpreting regulations related to case processing, ensuring compliance with industry standards and regulatory requirements.
• Having excellent knowledge in end-to-end Individual Case Safety Reports (ICSR) activities including case intake, triage, case processing, quality review and distribution.
• Extensive work experience in processing of spontaneous reports, CT (Clinical trial) reports, NIS (Non-Interventional Study) reports, literature reports, EV-WEB case processing and Vaccine case processing.

Advanced Postgraduate Diploma in Pharmacovigilance – Cliniminds, Hyderabad

Registered Pharmacist: (TS045462) - Telangana State Pharmacy council, Hyderabad, Telangana, India

Recognized and appreciated for being the top performer.

Qinecsa Star performer – 2023, 2024, 2025
Bioclinica Star Performer – 2020
Cognizant Star Performer – 2018
Cognizant Unicorn Award – 2017