• Services
    Applications Artificial & Augmented Intelligence Business Process Business Solutions Cloud
    Consulting Cybersecurity Data & Analytics Design & Experience Digital Marketing & Interaction
    Engineering Infrastructure Sustainability Talent Cloud
  • Industries
    Aerospace & Defense Automotive Banking Capital Markets Communications Consumer Electronics Consumer Packaged Goods
    Education Engineering Construction & Operations Healthcare Industrial & Process Manufacturing Insurance Life Sciences & Pharma
    Media & Info Services Medical Devices Natural Resources Network & Edge Providers Oil & Gas Platforms & Software Products Professional Services
    Public Sector Retail Semiconductors Transportation & Services Utilities
  • Insights
    Featured Insights From our CEO Business Strategy Digital Transformation Sustainability Technology Trends
  • About Wipro
    About Us Analyst Speak Awards and Recognitions Events Inclusion and Diversity Investors
    Lab45 Leadership Locations News Partner Ecosystem Sustainability
    The Story of Wipro Privacy at Wipro Supplier Diversity Wipro Ventures
  • Careers
  • Contact Us
Locations

America

country brazil Brazil En Po

country canada Canada

country latam Latam

country maxicoMexico En Sp

country usa United States

Europe En De

country benelux Benelux

country dach Germany & Austria En De

country nordic Nordic

country france Southern Europe En Fr

country switzerland Switzerland En De

United Kingdom & Ireland

Asia Pacific

countryAsean

countryAustralia & New Zealand

countryChina

countryJapan En Jp

countryKorea

countryTaiwan

India & Middle East

country IndiaIndia

countryMiddle East

Africa

countryGlobal Site

< Digital Operations and Platforms

Global Pharmacovigilance and Drug safety reporting

comments.png fav-article share icon
comments.png liked.png

Global Pharmacovigilance and Drug Safety Reporting

Experienced and highly trained pharmacovigilance professionals for your business

microsites_play_icon
X

microsites_play_icon
popup-image

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: 

  1. Around 96% case processing quality
  2. 40% efficiency improvement
  3. At least 3% productivity gains year-on-year
  4. 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. 

© 2023 Wipro
Disclaimer Privacy
X

Share Icon
popup-image

Contact Wipro

Please fill the required details to access the content

loading.gif