Pharmacovigilance involves all activities related to the detection, assessment, understanding and prevention of adverse events or problems related to medicines. It is essential for determining the safety profile of marketed drugs, for detecting adverse reactions, inappropriate uses, treatment failures and other complications not evidenced during the investigational stage of drugs.

Colombia has a National Pharmacovigilance Program led by INVIMA with the aim of monitoring the safety, effectiveness and quality of medicines at the marketing stage and includes the participation of all actors involved in the life cycle of the drug: patients, families, treating physicians, pharmacists, clinics and hospitals, health departments and pharmaceutical laboratories.

In Aruna Asesores, we have a Pharmacovigilance unit with professionals that are highly qualified in advising, analyzing and training on issues related to drug and patient safety, focused on the pharmaceutical and hospital industry, all of this in compliance with Colombian regulations, offering the following services:


  • Development and implementation of pharmacovigilance programs
  • Evaluation and periodic safety reports
  • Evaluation and implementation of risk management plans
  • Identification, monitoring, prevention and evaluation of:
    • Problems related to medicines at the marketing stage (chemical, biological and phytotherapeutic syntheses)
    • Identification of problems related to investigational drugs
    • Adverse event analysis and reporting
    • Identification of signs and medication errors
    • Causality analysis and assessment
    • Traceability of the adverse event
    • High-risk drugs
    • LASA medicines
  • Education:
    • Sales force training in the pharmaceutical industry
    • Training of the hospital population
    • Advice on research projects related to the area of pharmacovigilance
  • Consultancy in pharmacotherapy follow-up programs

Powered by