Pharmacovigilance

Pharmacovigilance is one of our top priorities in the Grupo Net V.

We have extensive experience to perform the medical evaluation and analysis of reports of adverse events. We have a specialized team in data capture, analysis and reporting process.

The Grupo Net V offers its clients access to specialized equipment, adapted to the needs of your project to help meet regulatory requirements in Latin America.

We offer a wide range of pharmacovigilance and safety monitoring, working with companies to achieve operational excellence.

Our medical professionals work closely with pharmaceutical companies, providing expert advice and support in the research stages or post-approval of products.

We complement the activities of existing Pharmacovigilance departments in pharmaceutical companies or, we develop the Pharmacovigilance system by local regulations required by outsourcing different services:

Post-adoption Services Product

  • Individual Cases Safety Reports (ICSR) - Evaluation, classification and processing
  • Management Progress Reports
  • Safety assessment and medical review
  • Preparation of Periodic Safety Update Reports (PSURs)
  • Review of medical literature
  • Development of Risk Management Plan (RMP)
  • Submission of notices of Adverse Events to Local Health Authorities in accordance with current regulations
  • Development of procedures of local labor
  • Development of training materials
  • Development of indicators (metrics) tailored to the needs of our clients

Services Research Products

  • Processing of serious adverse effects
  • Management Progress Reports
  • Medical Evaluation
  • Preparation of Narrative
  • Reconciliation of Serious Adverse Events