Wipro’s scalable operations for global pharma and biopharma companies to transform end-to-end pharmacovigilance (PV) drug safety service requirements
Wipro’s comprehensive and robust end-to-end pharmacovigilance system is augmented by its scientific and medical professionals with extensive experience, making it a leader in this field. Our team can support customers from clinical trial activities to data collection post market authorization complying with regulatory and quality requirements. We take pride in establishing and conducting vigilance activities across the globe for several pharmaceutical and medical device companies with the right setup and use of efficient tools to ensure that the data is properly collected and used for creating various safety documents.
Given the extensive requirements of pharmacovigilance and the high maintenance cost of resources and infrastructure, Wipro provides the related solutions required for scaling up, including the use of cutting edge technology, ensuring on-time reporting. Our pharmacovigilance services are driving efficiency and improving compliance for customers while reducing cost of safety data processing.
Wipro offers a highly specialized unit of medical professionals managing case processing, compliance activities as well as creating various aggregate reports based on therapeutic areas along with submission to regulatory bodies.
Wipro’s clients have gained the following benefits by adopting our PV transformation program:
- Around 96% case processing quality
- 40% efficiency improvement
- At least 3% productivity gains year-on-year
- Around 98% case regulatory submission compliance
Wipro provides services in the following areas to global pharma and bio-pharma companies
- Collection of adverse events data (serious and non-serious) via different means
- Case processing – Collection, triaging, data entry, QC and processing of Individual Case Safety Reports (ICSRs)
- Global and local literature monitoring services to help identify suspected adverse reactions
- Authoring, publishing and submission of safety reports including expedited and aggregated reports
- Signal detection
- Risk management
- Safety database infrastructure deployment
- Authoring of SOPs, pharmacovigilance System Master File (PSMF) documents and Qualified Person Responsible For pharmacovigilance (QPPV) enablement
Wipro's IP for Automation in Pharmacovigilance:
Wipro has developed a unique PV Automation Service Platform called TaloSafe for achieving a complete, correct, and compliant output through a global delivery model so that pharmacovigilance operations teams can ensure clinical and compliance corrections of cases.
TaloSafe includes intelligent automation driven by RPA, artificial intelligence, proprietary workflow engine, and operations management systems that enable you to customize processes and metrics to the client’s specifications. The framework lets you track the process, monitor metrics, and extract meaningful reports.