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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