• Managing worldwide cases for all product related safety information
• Complex System and proceses to manage Pharmacovigilance data.
• Missing data from Literature due to lack in search strategies and tracking
• Lack of system to handle huge amount of data for different molecules
• Huge time consumption on processing of big data and time wastage on reviewing the ICSR article multiple times
• Duplicate case handling – possible missing of data and also overlapping with direct reports from health professionals and clinical studies.
• High cost of manual entry
• Missing deadlines of Expedited Reporting
• Quality issues
• Training & Documentations

WE DO NOT PROVIDE JUST THE SERVICES, WE PROVIDE QUALITY ASSURED SERVICES

PHARMACOVIGILANCE CORE ACTIVITIES

• Collection and management of adverse drug reaction (ADR) data
• Case processing activities including case Triage, Causlaity assessment, Case entries, MedDRA & WHO DD coding etc.
• Preparing and development of PSMF, Risk Management Plans (RMPs), PSURs, PBRERs etc.
• Submitting expedited and aggregate reports
• Providing Pharmacovigilance Software/Database solution for ICSR management

PHARMACOVIGILANCE MANAGEMENT ACTIVITIES

• Preparing standard operating procedures (SOPs) and other controlled quality documents
• Management of internal and regulatory compliance reporting
• Testing and Validation of Pharmacovigilance processes and systems for compliance
• Performing trend analyses and predictive modeling for compliance operations
• Preparation and maintenance of Pharmacovigilance System Master File
• Preparation and review of safety data exchange agreements
• Quality and training system management and documentations
• Audit readiness system support
• Corrective and Preventative Action (CAPA) implementation