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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)

CONTACT US FOR MORE INFORMATION

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 FU
  • 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
  • Safety Data Exchange Agreements (SDEA) set up and maintenance
  • Global pharmacovigilance responsibilities in the EEA (QPPV and Deputy)
  • Annual basic training on general PV topics
  • 24/7 contact for local competent authorities and the COMPANY
  • Creation and maintenance of the Safety Management Plan
  • Pharmacovigilance System Master File (PSMF) preparation and maintenance
  • Registering the Organization in SPOR
  • Registering DMP/AMP in the XEVMPD
  • SAE receipt,
  • management and
  • assessment
  • Case Narrative writing
  • SAE
  • management FU
  • MedDRA coding
  • Safety information medical review and evaluation
  • SUSARs/CIOMS/MEDDEV 2.7 preparation and follow up
  • Safety information submission to Sponsors or MAHs
  • ICSR information reporting to EV
  • Creation of the global safety database.
  • Generation of line listings
  • Monitoring of changes in the local PV legislation
  • Preparation of periodic reports (PSURs/DSURs/ASR)
  • Submission of periodic reports (PSURs/DSURs/ASR)
  • Safety Data Exchange Agreements (SDEA) set up and maintenance
  • Pharmacovigilance responsibilities in the Territory (Local qualified person responsible for pharmacovigilance)
  • Annual basic training on general PV topics
  • 24/7 contact for local competent authorities and the COMPANY
  • Creation and maintenance of the Safety Management Plan
  • SAE receipt,
  • management and
  • assessment
  • Case Narrative writing
  • SAE
  • management FU
  • MedDRA coding
  • Safety information medical review and evaluation
  • SUSARs/CIOMS/MEDDEV 2.7 preparation and follow up
  • Safety information submission to Sponsors or MAHs
  • Safety information reporting to CAs and IRBs
  • Generation of line listings
  • Monitoring of changes in the local PV legislation
  • Preparation of periodic reports (PSURs/DSURs/ASR)
  • Submission of periodic reports (PSURs/DSURs/ASR)

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

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