GlobVigilance offers safety services to Affiliates in various countries providing all the services related to Pharmacovigilance activities.
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Senior Doctors
A wide scope of rigorous medical writing services, dedicated to a single document or part of a full clinical-trial program
Flexible and broad experience in using client templates, style guides and tailored requirements
Our own ICH-compliant templates in absence of a client template.
An experienced mediator of an interdisciplinary team to ensure delivery of cohesive documents that meet rigorous scientific quality standards and are compliant with ICH, regulatory standards and your own requirements
Far far away, behind the word mountains, far from the countries Vokalia and Consonantia, there live the blind texts. Separated they live in Bookmarksgrove right at the coast
Far far away, behind the word mountains, far from the countries Vokalia and Consonantia, there live the blind texts. Separated they live in Bookmarksgrove right at the coast
Far far away, behind the word mountains, far from the countries Vokalia and Consonantia, there live the blind texts. Separated they live in Bookmarksgrove right at the coast
Mailbox management on behalf of the affiliate
Management of Solicited Programmes
Local language, social media & Health Authority ICSRs
Local and non-indexed literature screening and review – in English as well as local languages
Analysis of gaps in local labels (SmPCs/PIs/PILs) and impact of safety assessment due to missing information in local labels
Adverse Drug Reaction form creation
Regulatory Intelligence
Compliance monitoring
Developing, tracking & reconciliation for affiliate activities
Translation services for CIOMS/narratives/ICSRs & other safety data
Case Intake, receipt, triage, case creation & acknowledgments
Supporting Audits and Inspections
Generation of line listings from Safety Database for local HAs
Maintaining database of local products and local SPC/label management
Training of local affiliates
Maintaining to Local Tracker
Manual upload of ICSRs & data entry into non-E2B HA database
Mailbox management on behalf of the affiliate
Management of Solicited Programmes
Local language, social media & Health Authority ICSRs
Local and non-indexed literature screening and review – in English as well as local languages
Analysis of gaps in local labels (SmPCs/PIs/PILs) and impact of safety assessment due to missing information in local labels
Adverse Drug Reaction form creation
Regulatory Intelligence
Compliance monitoring
Developing, tracking & reconciliation for affiliate activities
Translation services for CIOMS/narratives/ICSRs & other safety data
Case Intake, receipt, triage, case creation & acknowledgments
Supporting Audits and Inspections
Generation of line listings from Safety Database for local HAs
Maintaining database of local products and local SPC/label management
Training of local affiliates
Maintaining to Local Tracker
Manual upload of ICSRs & data entry into non-E2B HA database
