Pharmacovigilance Services

Jeevan offers comprehensive Pharmacovigilance and safety monitoring services from early development support through post-approval initiatives. We have experienced and skilled medical professionals with first-hand knowledge of regulatory requirements.


INDIVIDUAL CASE MANAGEMENT

  • Safety case processing
  • Data entry and triage
  • Case coding
  • Narrative writing
  • Quality control
  • Reporting

RISK MANAGEMENT PLAN

  • Risk management planning
  • Risk management plan development
  • Development of risk minimization
  • Assessment of risk minimization
  • Risk management studies

MEDICAL CALL CENTER

  • Adverse events
  • Product complaints
  • Medical information
  • 24 X 7 Support

AGGREGATE SAFETY REPORTS

  • Periodic Safety Update Reports (PSUR)
  • Benefit-risk evaluation report (PBRER)
  • Periodic Adverse Drug Experience Report (PADER)
  • Investigational New Drug (IND) – Annual Report
  • Developmental Safety Update Report (DSUR)

SIGNAL DETECTION

  • Signal Detection, Prioritization
  • Statistical Analysis in Large
  • Adverse Event Databases
  • Active Surveillance
  • Signal Assessment using Pharmacovigilance database

OTHERS

  • Literature search and medical information's
  • QPPV Support
  • Inspection and Audit support
  • Physical retrieval of damaged products and analysis