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Vigi-Care

Your key to pharmacovigilance compliance

Services

Routine / non-routine pharmacovigilance operational 

processes:

 

  • Qualified Person for Pharmacovigilance {QPPV} Duties

  • Affiliate Local Pharmacovigilance Person {LPVP}

  • Safety case management cycle

  • Aggregate reports management cycle

  • Literature screening

  • Signal management

  • Risk management plan

  • Risk minimisation measures (RMMs)

  • Medical Monitoring

  • Safety Data / Narrative management

    • Narrative writing​

    • ​Narrative Medical Reviewing

  • Pharmacovigilance Document Management

    • Safety Data Exchange Agreements (SDEA)

    • Safety management plan (SMP)

    • Pharmacovigilance Quality Management Plan (PVQMP)

    • Service Level Agreement (SLA)

  • Advertising / Promotional Material Medical Approval (EU / Non-EU countries)

Safety Management Compliance Tools

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  • Pharmacovigilance Compliance Tools {Basic/Advanced}

  • Non-Conformity Management {NC/CAPA Tracking Tools}

  • Safety Project Progress Assessment 

  • Key Performance Indicators (KPIs)

  • Monitoring/Tracking Tools

  • Audit Trails

  • Standard Operation Procedures {SOPs) / Working Instructions (WINs)

  • Pharmacovigilance Tools Compliance Plan

Vigi-Care

 

• Providing Pharmacovigilance Services and expertise to meet the complex regulatory requirements in pharmacovigilance, which is        subjected to recent updates in the last two years.

• Committed to manage the pharmacovigilance tasks that are required during the medicinal products’ life cycle. Full coverage for

   product safety from Phase I to IV clinical studies relevant across a broad spectrum of theraputic areas.

• Ensuring effective collaboration with Marketing Authorisation Applicants / holders (MAA / MAH), providing flexible solution to

   manage dedicated tasks with ensured compliance and adherence to authorities’ régulations.

Commitment

  • Pharmacovigilance System Compliance

  • Pharmacovigilance due diligince

  • Pharmacovigilance Strategic Plans
  • Pharmacovigilance Organisation Chart Optimisation
  • Regulatory Surveillance / Intelligence
  • Pharmacovigilance Inspection Compliance / Readiness
  • Pharmacovigilance Educative Trainings {Knowledge, Perception, Practice and Compliance}
  • Pharmacovigilance Service Providers Compliance Management
  • Pharmacovigilance System Master File {PSMF} Preparation
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