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PHARMACOVIGILANCE

PHARMACOVIGILANCE SERVICES IN SPAIN, ITALY AND PORTUGAL

We understand pharmacovigilance as the process of monitoring the safety of Development Medicinal Products (DMP), Authorized Medicinal Products (AMP) and Medical Devices, taking action to identify and evaluate adverse reactions to reduce the risks. We offer our services in Spain, Italy and Portugal.

HOW WE WORK IN PHARMACOVIGILANCE

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

MAIN PHARMACOVIGILANCE SERVICES

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  • European QPPV (Qualified Person responsible for Pharmacovigilance)

  • Local QPPV in Spain, Italy and Portugal

  • Serious Adverse Event (SAE) receipt, management and assessment

  • Case Narrative writing

  • SAE management Follow up

  • MedDRA coding

  • Safety information medical review and evaluation

  • SUSARs/CIOMS preparation and follow up

  • Safety information submission to Sponsors

  • Individual Case Safety Report (ICSR) information reporting to EudraVigilance

  • Preparation and submission of periodic reports (PSUR, DSUR and ASR)

ALL PHARMACOVIGILANCE SERVICES

  • Set up and maintenance of the Safety Data Exchange Agreements (SDEA)
  • Global pharmacovigilance responsibilities in the European Economic Area:
    • Qualified Person Responsible for Pharmacovigilance (QPPV)
    • Deputy
  • Pharmacovigilance responsibilities in the Territory: Local qualified person responsible for pharmacovigilance
  • 24/7 contact for local competent authorities and the company
  • Creation and maintenance of the Safety Management Plan
  • Preparation and maintenance of the Pharmacovigilance System Master File (PSMF)
  • Registering the Organization in Substance and product data management services (SPOR)
  • Registering AMP in the Extended EudraVigilance medicinal product dictionary (XEVMPD)
  • Serious Adverse Event (SAE) receipt, management and assessment
  • Case Narrative writing
  • Serious Adverse Event (SAE) management Follow up
  • MedDRA (Medical Dictionary for Regulatory Activities) coding
  • Safety information medical review and evaluation
  • Suspected Unexpected Serious Adverse Reaction (SUSARs) and Council for International Organizations of Medical Sciences (CIOMS) preparation and follow up
  • Safety information submission to marketing authorisation holders (MAHs)
  • Individual Case Safety Report (ICSR) information reporting to EudraVigilance (EV)
  • Creation of the global safety database
  • Generation of line listings
  • Strategy Preparation for literature researches
  • Local weekly literature searches
  • Global signal detection and assessment
  • Assessment of local quality complaints
  • Evaluation and notifications of critical safety concerns (emerging safety issues)
  • Incident Reporting and Safety Corrective Action management
  • Preparation, maintenance and management of Risk Management Plans (RMPs)
  • Preparation of the Periodic safety update reports (PSURs)
  • Submission of the Periodic safety update reports (PSURs)
  • Communications with and submission of responses to safety-related enquiries to the competent authorities (PAS)
  • Entry of information into Extended EudraVigilance medicinal product dictionary (XEVMPD)
  • Notification of any new authorised and marketed products along with all relevant details, including type of registration procedure, pharmaceutical presentations and authorities’ commitments
  • Provision of copies of any approved product information and any request of changes
  • Tracking of timeliness and submission of safety variations in the Territory
  • Set up and maintenance of the Safety Data Exchange Agreements (SDEA)
  • Global pharmacovigilance responsibilities in the European Economic Area:
    • Qualified Person Responsible for Pharmacovigilance (QPPV)
    • and Deputy
  • 24/7 contact for local competent authorities and the company
  • Creation and maintenance of the Safety Management Plan
  • Preparation and Mmintenance of the Pharmacovigilance System Master File (PSMF)
  • Registering the Organization in Substance and product data management services (SPOR)
  • Registering Development Medicinal Product (DMP) in the Extended EudraVigilance medicinal product dictionary  (XEVMPD)
  • Serious Adverse Event (SAE) receipt,management and assessment
  • Case Narrative writing
  • Serious Adverse Event (SAE) management and Follow up
  • MedDRA (Medical Dictionary for Regulatory Activities) coding
  • Safety information medical review and evaluation
  • Suspected Unexpected Serious Adverse Reaction (SUSARs) and Council for International Organizations of Medical Sciences (CIOMS) preparation and follow up
  • Safety information submission to Sponsors
  • Individual Case Safety Report (ICSR) information reporting to EudraVigilance EV
  • Creation of the global safety database.
  • Generation of line listings
  • Preparation of Development Safety Update Report (DSURs)
  • Submission of Development Safety Update Report (DSURs)
  • Set up and maintenance of the Safety Data Exchange Agreements (SDEA)
  • Pharmacovigilance responsibilities in the Territory: Local qualified person responsible for pharmacovigilance
  • 24/7 contact for local competent authorities and the company
  • Creation and maintenance of the Safety Management Plan
  • Serious Adverse Event (SAE) receipt, management and assessment
  • Case Narrative writing
  • Serious Adverse Event (SAE) management and follow up
  • MedDRA (Medical Dictionary for Regulatory Activities) coding
  • Safety information medical review and evaluation
  • Suspected Unexpected Serious Adverse Reaction (SUSARs) and MEDDEV 2.7 preparation and follow up
  • Safety information submission to Sponsors
  • Safety information reporting to Competent Authorities (CAs) and Institutional Review Boards (IRBs)
  • Generation of line listings
  • Monitoring of changes in the local Pharmacovigilance legislation
  • Preparation of the Annual Safety Report (ASR)
  • Submission of the Annual Safety Report (ASR)

Ready to work together?

Leon Research is a Contract Research Organization (CRO) providing full services in Spain, Italy and Portugal.