BCIRG
 |
|
|
 |
Drug Safety and Pharmacovigilance
The Drug Safety & Pharmacovigilance department addresses, coordinates and centralizes all the Safety issues and all Pharmacovigilance tasks i.e. SAEs reporting.
The department has developed processes and standard operating procedures and has organized the filing of electronic and paper serious adverse events (SAE) and safety guidelines. This maintains accurate pharmacovigilance records for each study and fulfills regulatory requirements with respect to quality and time constraints. The process involves a medical review, administration of and dissemination of the SAE reports to all parties involved (investigators, monitors, sponsors and Health Authorities) in a timely fashion.
These activities are supported by the Pharmacovigilance (PV) database.
The team is composed of:
-
The Director
-
Drug Safety Managers
-
Administrative Safety Coordinators
-
Administrative Assistant
The Goals of the Drug Safety and Pharmacovigilance Team are:
-
To meet the ICH/GCP and FDA requirements for SAE expedite reporting.
-
To track and process all SAEs according to the sponsor's regulatory requirements.
-
To set-up and maintain accurate safety monitoring of the patients enrolled in CIRG studies.
The Drug Safety and Pharmacovigilance Team's Activities are:
To ensure compliance with the FDA, EEC, any other local Regulatory requirements and respond to the Sponsor's needs, the team's responsibilities are to:
-
Track, acknowledge and forward reported SAEs to the sponsor and site according to the SAE reporting Plan.
-
Review each SAE for medical consistency, accuracy, completeness and follow-up until satisfactory resolution.
-
Develop Safety strategy and processes in conjunction with the sponsor in order to respond to Sponsor's needs whenever applicable.
-
Develop SAE Reconciliation Plan, including process and responsibilities, defined data fields to be checked and timelines.
-
Generate monthly standardized reports to the sponsor and the Project Team using the Pharmacovigilance database.
-
Provide periodic safety reports for the Independent Data Monitoring Committee, Investigator Newsletter, and EC/IRB.
-
Expedited IND Safety report issued by the Sponsor.
-
Train and support the Project Management and Monitoring teams on Safety issues and SAE reporting procedures.
