Pharmacovigilance: Drug Safety
The ORION Pharmacovigilance group includes Drug Safety Physicians and Drug Safety Executives.
ORION'S stand-alone pharmacovigilance system has the flexibility of function to allow us to tailor the service we provide to our sponsors' needs. It supports standard dictionaries including MedDRA and meets worldwide regulatory requirements. It also allows us to generate customer specific reports in addition to electronic submissions for regulatory authorities or Ethics/IRBs, and has comprehensive security functions.
ORION has also developed a robust process for the management of pharmacovigilance data, including a 24 hour, 7 day a week emergency contact number for SAE reporting.
Our services include:
- Logging, tracking and reporting of Serious Adverse Events (SAEs) to clients and regulatory authorities (including the posting of safety data onto the ORION Web Server)
- SAE data coding
- Generation of MedWatch and CIOMs
- Overall harmonisation of SAE database
- Reconciliation of Pharmacovigilance and clinical databases
- 24 hours/7 days emergency coverage