Serves as Database Administrator for Argus Safety, including database configuration, issue resolution, maintenance, governance and daily support
Performs installations, upgrades, configuration of reporting rules, and E2B reporting via gateway technologies (including set-up and configuration of Axway Gateway Interchange)
Provides support for all systems associated with PV and drug safety
Performs updates to Argus configuration and processes as per changing Eudravigilance regulations
Provides support and execution of activities related to Eudravigilance testing for various clients
Performs case migration/database transfers, file importing and supports other case processing activities
Provides leadership in executing Argus upgrades and related activities
Provides administrator support for other safety databases (such as ARISg)
Performs periodic coding dictionary (MedDRA & WHO drug) updates for Argus
Provides technical assistance and support to Drug Safety Associate team with electronic submissions of serious adverse advents to European agencies
Writes procedural documents including Standard Operating Procedures (SOP), Work Practice Documents, and Data Entry Manuals for Argus Safety
Generates case processing metrics, reviews and makes suggestions and supports process improvement implementation
Maintains technical expertise of regulatory requirements and ensures alignment with company working practices
Assists with business development and capabilities efforts as needed
Interacts directly and independently with client to coordinate all facets of projects; competent communicator, supports client capabilities as PV/drug safety systems SME
Strong understanding and experience working with Argus configuration and study set up
Strong understanding of global case processing and SAE reporting
Strong understanding of global clinical trial development and data