SRIDEVI KALLURI

Support global pharmacovigilance operations by reviewing, validating, and tracking safety data in compliance with international regulatory timelines.

Experience in compliance documentation and process tracking using global pharma tools (LSMV ArisG), ensuring adherence to quality standards.

Handle various case types, including spontaneous, clinical trial (CT), Patient Support Programs (PSP), and Post-Authorization Programs (PAP), ensuring scientific accuracy and timely submissions.

Streamlined communication between departments to enhance collaboration and efficiency.

• Processed over 700 Individual Case Safety Reports (ICSRS), ensuring accuracy and compliance with global regulatory standards.
• Reduced data entry errors by 15% through the implementation of self-quality checklists.
• Utilized Argus Safety Database for efficient case processing, triage, and data validation.
• Contributed to Novartis' Patient Oriented Program (POP) and Managed Access Program (MAP), ensuring timely and compliant safety data management.
• Collaborated with cross-functional global teams to ensure data accuracy and adherence to safety protocols.
• Identified and escalated potential safety issues, maintaining strict compliance with regulatory standards.
• Contributed to the development of standard operating procedures, promoting consistency in drug safety practices.

• Conducted initial OPD and IPD assessments, providing patient counseling on medications and lifestyle adjustments.
• Assisted in the discharge process, including handling of summaries and medication counseling.
• Supported surgeons during consultations and surgeries, ensuring seamless care coordination.
• Managed patient data using HINAI Web, a comprehensive hospital information management system (HIMS) that streamlined operations, improved patient care, and reduced costs by integrating electronic medical records (EMR), workflow configurations, and centralized patient data access.
• Exhibited excellent problem-solving skills when encountering complex medical cases, collaborating with physicians and other healthcare professionals to determine the most appropriate course of action for optimal patient outcomes.
• Recorded patient history to accurately track conditions, progress and diagnosis for comprehensive medical records.