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Pharmacovigilance Services

We offer pharmacovigilance services for human use and veterinary during the study and once marketing authorization is available.

PHARMACOVIGILANCE FOR HUMAN USE

Pharmacovigilance services in Spain, Italy and Portugal

We understand pharmacovigilance as the process of monitoring and evaluating the safety and benefit/risk balance of a medicinal product throughout its lifecycle, both in the clinical phases and in the marketing period.

Likewise, monitoring the safety of medical devices is essential to prevent and reduce the recurrence of incidents related to their use.

How we work at León Research:

We provide a high-quality pharmacovigilance service by creating a specific plan for the safety system to be followed in each study, adapted to the Good Pharmacovigilance Practice Guidelines included in the European Union Legal Framework.

Pharmacovigilance of medicinal products and medical devices safety is carried out under the Good Pharmacovigilance Practices, national legislations and European regulations following the highest quality standards to ensure compliance with safety requirements.

Main Pharmacovigilance Services

European QPPV (Qualified Person responsible for Pharmacovigilance)
Local QPPV in Spain, Italy and Portugal
Responsible Person for Clinical Trials
Serious Adverse Event (SAE) collection, management and assessment
Case Narrative writing
MedDRA coding
Individual Case Safety Report (ICSR) information reporting to EudraVigilance
Preparation and submission of periodic reports (PSUR, DSUR and ASR)
Safety information medical review and evaluation
CIOMS preparation and SUSAR reporting.
Safety information submission to Sponsors

Pharmacovigilance for human use

1 · AUTHORIZED MEDICINAL PRODUCTS (AMP)

1 · AUTHORIZED MEDICINAL PRODUCTS (AMP)

  • Set up and maintenance of the Safety Data Exchange Agreements (SDEA)
  • Qualified Person Responsible for Pharmacovigilance (QPPV) & Deputy
  • Local QPPV
  • 24/7 contact for local competent authorities and the company
  • Creation and maintenance of the Safety Management Plan
  • Preparation and maintenance of Safety Documents (PSMF, RMP)
  • MedDRA (Medical Dictionary for Regulatory Activities) coding
  • Individual Case Safety Report (ICSR) information reporting to EudraVigilance (EV)
  • Strategy Preparation and local literature searches
  • Preparation and submission of the Periodic safety update reports (PSURs)
2 · DEVELOPMENT MEDICINAL PRODUCTS (DMP)

2 · DEVELOPMENT MEDICINAL PRODUCTS (DMP)

  • Creation and maintenance of the Safety Management Plan
  • Collection, management and assessment of Serious Adverse Events (SAEs)
  • Preparation and drafting of safety case narratives 
  • MedDRA coding
  • Preparation of CIOMS forms and reporting of RAGIs
  • Creation of the global safety database
  • Preparation and submission of periodic reports (DSUR))
3 · MEDICAL DEVICES (MD) under development or CE marked

3 · MEDICAL DEVICES (MD) under development or CE marked

  • Creation and maintenance of the Security Management Plan
  • Establishment and maintenance of the Safety Management Plan
  • Collection, management and assessment of serious adverse events (SAEs)
  • Writing case narratives
  • MedDRA coding
  • Preparation and monitoring of MDCG 2020-10/2
  • Establishment of the global safety database
  • Reporting of safety information to Competent Authorities and Independent Ethics Committees (IECs)
  • Preparation and submission of periodic reports (ASRs)

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Pharmacovigilance Glossary

  • Any undesirable or unintended effect that occurs with a drug, used in its normal dosage, for which a causal relationship cannot be ruled out.

    ADR can be separated from AE by the possible/probable/certain causal relationship.

VETERINARY PHARMACOVIGILANCE

Veterinary Pharmacovigilance

We understand veterinary pharmacovigilance as the science and activities related to the detection, evaluation, understanding, and prevention of suspected adverse events or any other problem related to a veterinary drug.

At León Research we provide a high-quality pharmacovigilance service in each study, creating a specific plan for the safety system to be followed for each project, adapted to the Guides for Good Pharmacovigilance Practices included in the legal framework of the European Union 2019/6, which entered into force on January 28, 2022.

Main veterinary pharmacovigilance services

Veterinary QPPV in Europe
Preparation and maintenance of the PSMF
Risk management plan including signal detection
Record of adverse events in EVVET
Adverse event reports
Literature research
Management and internal audits of the PV quality management system
Training plan in PV

How can León Research help veterinary health professionals? 

  • Preparation of the Pharmacovigilance System Master File (PSMF)
  • Initial training on PMSF management
  • Pharmacovigilance System Master Plan Maintenance
  • Initial registration of suspected adverse events and additional data collection
  • Preparation of reports of adverse events and additional data to present to the health authorities
  • Assessment of causality in all adverse events
  • Carrying out internal audits of the Pharmacovigilance system
  • Monitoring of the quality, integrity and content of the information registered in the pharmacovigilance system, including the information reported to the European Union Database (EVVET) and search for duplicates.
  • Record of adverse events in EVVET
  • Document management and archiving system for relevant documentation
  • Risk Management Plan: including signal detection, continuous benefit/risk monitoring and a communication plan
  • Pharmacovigilance training plan for all personnel involved in the commercial, quality, distribution, auxiliary personnel, etc.
  • Literature research
  • Preparation of a model agreement on pharmacovigilance with drug distribution entities (commercial veterinary distributors)

Contact us for more information 

Name *
Email *
Company *