Pharmacovigilance Support
CEBIS supports pharmacovigilance activities including adverse-event case intake and follow-up, literature surveillance, safety-data reconciliation, risk-management support, safety documentation, training and operational PV coordination.
Services can be structured around specific safety activities or coordinated as part of a broader outsourced pharmacovigilance model.
Operational Support for
Adverse Event Case Processing
Support case intake, follow-up and processing of adverse-event information.
Literature Surveillance
Review product-safety information identified through relevant literature sources.
Safety Reconciliation
Coordinate periodic reconciliation of relevant safety information.
PV Documentation
Support maintenance of appropriate pharmacovigilance documentation.
Risk Management
Support activities associated with risk-management plans and risk-minimization measures.
Vendor Coordination
Coordinate relevant PV responsibilities across third parties where included in the safety model.
From Safety Information
Case Intake
Receive safety information through the agreed reporting channels.
Data Verification & Follow-Up
Review available information and seek additional details where required.
Medical & Drug Coding
Structure relevant event and product information for case processing.
Case Assessment
Support review of the available case information.
Reporting
Prepare the case for the appropriate downstream safety-reporting process.
Monitoring Information
Beyond Individual Cases
Pharmacovigilance also requires review of safety information coming from sources beyond direct adverse-event reports.
Support can include:
- Literature-based safety review
- Identification of relevant product-safety information
- Review of emerging safety information
- Coordination of findings with the wider PV process
- Follow-up where information may require further evaluation
Supporting Ongoing
PSMF Support
Support maintenance and update activities associated with the pharmacovigilance system master file where within scope.
Risk Management Plans
Support appropriate documentation and activities related to product risk management.
Risk-Minimization Measures
Support coordination of approved actions intended to communicate or manage identified product risks.
Safety Coordination
Connect lifecycle safety activities with the relevant regulatory and medical teams.
Processes and People
PV Training
Support teams in understanding appropriate safety-information handling and reporting responsibilities.
Safety Translation Review
Provide quality review for translated or transcribed safety information where required.
Local Coordination
Support appropriate local PV communication models where confirmed.
Vendor Management
Coordinate defined safety responsibilities involving external providers.
Structured Processes for Safety Information
Defined intake channels
Safety-information processing
Case-management workflows
Appropriate reporting pathways
Data review and quality checks
Documented escalation and communication
Flexible Safety Support Based on the Sponsor’s Needs
Focused PV Support
Outsource an individual safety activity or defined group of functions.
Expanded Functional Support
Add operational capacity where the sponsor retains wider pharmacovigilance leadership.
Broader Outsourced Model
Coordinate multiple safety activities through a defined governance and responsibility model.
Safety Connected to the
Pharmacovigilance should remain aligned with clinical and regulatory teams throughout development.
CEBIS can connect PV activities with:
- Medical Monitoring
- Clinical Operations
- Data Management
- Regulatory Affairs
- Medical Writing
- Quality Oversight
Need Pharmacovigilance Support?
Tell us about the product, development or marketing stage, geographic scope and safety activities you require. A member of the CEBIS team can discuss an appropriate pharmacovigilance support model.