Pharmacovigilance

Our Safety vigilance Unit provides a wide range of services, including:

Preparation of the Safety Data Exchange agreement (SDEA) or Safety Management Plan (SMP) for open-label and blinded studies
Collection, assessment and reporting of Adverse Events (AEs) originating from clinical studies
Query management and follow-up
MedDRA coding
Set up and implementation of a validated eSafety tool module for the collection and reporting of AEs, SAEs, Pregnancy cases and Product Quality Complaints through electronic systems
SAE Reconciliation Process
SUSAR Submission through the Eudravigilance database
SUSAR submission to local regulatory authorities through our subsidiaries
Management of SUSARs Line Listing: list drafting and distribution
Development and submission to the Health Authorities (safety report) of Development Safety Update Reports (DSURs)
Wide experience in European regulatory requirements for pharmacovigilance (Regulatory intelligence)
Medical Review

Preparation of the Safety Data Exchange agreement (SDEA) or Safety Management Plan (SMP)
Participation in Safety Advisory Board
Case processing (ICSRs) and reporting
Management of local literature screening
Pharmacovigilance Business Continuity on holidays
Medical Review

Preparation of the Safety Management Plan (SMP) for Medical Device (In-Vitro Diagnostics Device -IVD- and Medical Device -MD-)
Management of Medical Device safety information (-IVD and MD) from Clinical Investigation and Post-Marketing Surveillance
Processing of a Medical Device Incident (MDI), Adverse Device Effects (ADEs) and Deficiency
Reporting of MDI/ADE to the Regulatory Authorities
MDI/ADEs reconciliation

Preparation of the Safety Data Exchange agreement (SDEA) or Safety Management Plan (SMP)
Collection, assessment and reporting of Adverse Events (AEs)
AE Reconciliation Process