1. Analysis and design of the Pharmacovigilance and/or Technovigilance Unit

2. Implementation of Standard Operating Procedures (SOPs)

3. Training

1- Implementation and Maintenance of the Pharmacovigilance and/or Technovigilance Unit.

2- Continuous monitoring of the product safety profile: Post-Marketing Surveillance.

3- Management of Suspected Adverse Reaction/Incident Reports.

4- Staff training within the organization.

5- Preparation of Periodic Safety Reports.

- Interpretation of regulatory standards and review of documentary material (Procedures and Formats).

- Management of Suspected Adverse Reaction and Incident Reports.

- Pharmacovigilance and Technovigilance in Patient Support Programs (PSP).

- Scheduling and execution of corrective and preventive actions (CAPA) that may arise as a result of these audits.

1- Management and handling of Suspected Adverse Reaction (SAR)/Adverse Incident (SAI).

2- Causality assessment of cases, according to the approved algorithm.

3- Assigned personnel to provide 24/7 support.

1- Planning, preparation, and submission of Periodic Safety Reports (PSR) to the national authority.

2- Preparation and/or adaptation of Risk Management Plans (RMP), according to current national regulations.

3- Advice and planning of risk minimization activities and/or additional pharmacovigilance activities.

1- Specialized training for Pharmacovigilance and/or Technovigilance Officers in functions, implementation, and management of their area.

2- Training aimed at staff in specific areas (sales, call center, complaints reception, etc.) to promote the communication of SAR/SAI.

3- Other specific trainings and courses in Pharmacovigilance and/or Technovigilance according to customer needs.

1- Review of the main national medical journals.

2- Identification of case reports that may involve products marketed by TRS.

3- Notification management until submission to the authority.

Safety is a fundamental commitment of the Pharmaceutical Industry to Human Health. Conkomerco is a company focused on Health Surveillance services, committed to Patient Health and Safety. We have:

- A Professional Health Surveillance Team

- A Solid Quality System

- The Conkomerco Algorithm Platform and Conkomerco Academy.

Conkomerco is a company focused on Patient Safety, in strict adherence to technical-regulatory requirements, guaranteeing confidentiality in the operations carried out by our specialized team for customer satisfaction.

Pharmacovigilance of medicines and medical devices at the national level is constantly developing and evolving. There is a need to establish and improve the reporting culture among healthcare professionals and the population.

In 2017, a group of healthcare professionals, recognizing the unmet need in the pharmaceutical industry to understand and monitor the benefit-risk profile of their products and their impact on Public Health, decided to create Conkomerco, an organization specialized in Pharmacovigilance and Technovigilance.

The word Conkomerco comes from the Esperanto language, with the root word “Komerco” referring to “business/commerce,” and together it means: “With business, we can solve it.” Just as Esperanto aimed to unify languages for harmonious international communication, Conkomerco seeks to promote social responsibility in the national and international pharmaceutical industry.

Over the years, we have decided to incorporate new proposals that allow the development of the National Pharmacovigilance and Technovigilance System, one of which is “El Centinela,” an informative bulletin that, in compliance with existing regulatory requirements, promotes scientific information related to Public Health.