Vigi Medsafe is an established Pharmacovigilance service provision company with its presence in India, Europe and the USA. It is an ISO 9001:2008 and ISO 27001:2013 certified company and combined this with its strong leadership, 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.