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Vigi Medsafe is an established Pharmacovigilance service provision company with its direct presence in India, and the USA and indirect presence in the EU. Focussed domain knowledge combined with its strong leadership, Vigi Medsafe will ensure the following are fulfilled the first time and every time.

The company has

  • Quality Management System comprising of SOPs, Policy documents and Quality Manual
  • Comprehensive list of PV SOPs covering key components in pharmacovigilance.
  • Peer review/Quality assessment at each level to minimize errors
  • Strong in-house training covering all aspects of PV including GVP modules
  • Audit readiness – for new clients, current partners, and health authority enquiries

The company has in place

  • Highly qualified, experienced associates with pharmaceutical and medical backgrounds
  • Thoroughly trained on multiple safety and literature databases that are compliant as per HA requirements
  • Thorough analysis of cases and literature from the point of receipt/identification till reporting
  • Highly secure environment for data protection, privacy and confidentiality

Vigi Medsafe is highly educated in terms of Pharmacovigilance Regulatory compliance for

  • Various types of ICSRs in case processing
  • Submission of aggregate reports
  • Development of Risk Management plans with all appropriate sections
  • Creating company core safety information and updating all existing labels
  • Signal evaluation scheduling and submission of reports
  • Literature review and analysis

Vigi Medsafe believes in establishing strong partnerships and maintaining them by the following

  • Ensuring PV processes and systems are compliant and the partner is 24/7 ready for PV Audits and Inspections.
  • Support in Preparation of CAPA (Corrective and Preventive Action) wherever required
  • Support for PV Inspection preparation
  • Establishment of business continuity plan during unforeseen circumstances

Irrespective of prospective’s size and location, Vigi Medsafe can provide solutions that are tailored in terms of selection of databases, deployment of resources and infrastructure, operative models and delivery mechanisms.



  • US $15 million company by 2020
  • Top 20 pharmacovigilance service provider
  • Global presence with footprint in India and the USA
  • Increase the scope of services to include global regulatory submissions and PV audits


  • To have a global presence addressing the needs of pharmaceutical companies and CROs irrespective of their size
  • To expand the network with like-minded organisations and build value propositions that create win-win-win situations to all
  • To implement validated state-of-art technological architectures and create an economically viable solution for all


  • “Quality” as single point agenda
  • Strict “adherence” to regulatory standards
  • “Transparent” and “tailored solutions” to partners
  • “U” is always before “I” in our value chain
  • “Satisfied” clients, partners, and all team members is paramount


Vigi Medsafe was founded in Hyderabad by 4 dedicated pharmacovigilance enthusiasts from Novartis.


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Establishment of UK / EU presence


Establishment of USA office to explore new growth opportunities and deliver the same quality

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