Pharmacovigilance

Pre-marketing

Development of Safety Management Plan
Preparation and Submission of Aggregate Safety reports and Line Listings
Writing and / or Reviewing Safety Agreements
Review of Safety Section of Study Protocol
SAEs / SUSARs Expedited Reporting to NCA and Ethics Committees
Pharmacovigilance Trainings to CRAs and Investigators
Development of Dear Investigator Letter
Reconciliation of Safety database with Clinical database
Medical Monitoring
Safety Physicians

Medical Device Vigilance

Provision of Responsible Person
Collection, assessment, and reporting of medical device incidents
Preparation of Periodic Summary Reporting
Preparation of Field Safety Notice & Field Safety Corrective Action
Set-up of Medical Device Vigilance System (MDVS)

Cosmetovigilance

Reporting of Serious Undesirable Events (SUEs)
Safety Assessment
Post-Marketing Surveillance
Provision of Responsible Person

Post Marketing

Comprehensive Management of ADRs / AEs
PV Safety Database
PV System and QMS Set-up and Maintenance
Writing and /or Review of PV SOPs
Preparation of PSMF & PSSF
QPPV and Deputy QPPV Provision (Middle East, North Africa, and Africa)
Preparation of Risk Management Plan (RMP) and Material of Additional Risk Minimizations
Audit/Inspection Readiness Training
PV Audit Conduct
Provide PV Trainings
Insourced and Outsourced PV Staff
Preparing and /or Reviewing Safety Data Exchange Agreements (SDEAs)
Medical Information Handling
Preparation and Submission of PSURs, PBRERs, and Addendum to Clinical Overview (ACOs)
Local and Global Scientific Literature Monitoring
Signal Management

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