Pharmacovigilance And Safety Services

Supporting clients with logistical and technical requirements to conduct change control, review, edit and Quality Check


Indegene recognizes pharmacovigilance and safety as key areas of strategic partnership as we create dedicated CoE programs that mirror the sponsor organization.

For more than a decade, Indegene has been supporting the pharma, life sciences, and medical device companies as a strategic scientific partner offering large-scale offerings in medical call center management, literature searches (safety searched), events coding, safety narrative writing, and coordinating closely with the regulatory bodies across the world. Indegene stands apart as a pharmacovigilance and safety partner to its clients by aligning services and adding risk management consulting and signal detection through strategic partnerships.
 

Suite of service offerings include:

 

  • ICSR Processing

    • Case Intake

    • Case Processing

    • Medical Review

    • Expedited Reporting

  • Literature Search/Safety Searches

  • Signal Detection and Analysis

  • Benefit-Risk Evaluation Reports

  • Safety Assessment Reports

  • RMPs/REMs

  • Safety/Patient Narratives

  • Aggregate Reports:

    • DSUR/PSUR/CAR/PBRER

    • SBR/PSUR Addendum/Addendum CO

    • PADER

  • Clinical Summaries: SCS/ISS/SCE/ISE Reports

  • Clinical Overviews: Renewal COs, Labeling Justification Document, ADR Frequency and Category CO and Article 46

  • Response to Health Authority Queries

  • Health Hazard Assessment Report

  • Legacy Report Conversion and Reconciliation