Pharmacovigilance

Indus Research ADVANTAGE

IR excels in providing end to end effective monitoring of safety and efficacy for Medicines, Medical Devices, Vaccines, Biologics & Nutraceuticals. IR is run and managed by medical doctors who have evolved from the Industry of Clinical Research and Pharmacovigilance or Pharmacovigilance (PV) Outsourcing. We have handpicked best talent and trained them on robust IR curriculum to deliver best in class service and experience to our all pharma clients.

ONGOING SUPPORT

    • Pharmacovigilance Development Plan – SOP writing, Implementation, Training on PV content
    • Case Intake and Monitoring – Call center activities for AEs, PQCs and MI, Validity, Duplicate Check, Reportability, Triage
    • AE/ SAE/ processing – Data Entry, Coding, Narrative Writing, Validation, Medical Review, Submission to DRAP, Follow-up, Compliance
    • Literature Search & Insights

PREDEFINED SUPPORT

  • Aggregate Reports – DSURs, PSURs, PADERs, PBRERs
  • Signal Detection, Prioritization, Evaluation
  • Risk Management Plans (RMPs)
  • Labelling Updates
PREDEFINED SUPPORT
ADHOC SUPPORT

ADHOC SUPPORT

  • Medical Monitoring
  • Risk-Benefit Assessment
  • Regulatory Authority Requests
  • Audit/ Inspection readiness, Mock-Audits

PHARMACOVIGILANCE OUTSOURCING SERVICES

  • Medical Information Call Centre
  • Follow up with reporters
  • Literature Search
  • Case Collection
  • Case Processing (in process)
  • Quality Check
  • Medical Review
  • Paper, SRP, ESG Submissions
  • Reconciliation
  • PI/IRB Submissions
  • Periodic Reports
  • QPPV Support
  • Signal Management
  • Regulatory Intelligence
  • Risk Management
  • Data Quality Management
  • PMS and PASS
  • Metrics Management

Pharmacovigilance Systems have been moving towards better environment and better reporting platforms. This change was initiated by Drug Regulatory Authority of Pakistan which is accepting E2B(R3) reports.

WANT TO WORK WITH US

We are always looking for new challenges and interesting parterns. Also, we love to say hello.