Senior Pharmacovigilance System Architect (Argus Administrator) - US

Roles & Responsibilities

• 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
• Performs case migration/database transfers, file importing and supports other case processing activities
• Provides leadership in executing Argus upgrades and related activities
• Performs 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
• Affords technical support and assistance to client projects
• 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

Requirements

• College graduate Information Technology discipline or related field, or relevant experience
• Minimum of 5 years’ experience in Information Technology or similar field required
• Expert knowledge of scientific principles and concepts
• Reputation as emerging leader in field with sustained performance and accomplishment
• Proficiency with MS Office applications
• Hands-on experience with clinical trial and pharmaceutical development preferred
• Good communication skills and willingness to work with others to clearly understand needs and solve problems
• Excellent problem-solving skills
• Good organizational and communication skills
• Familiarity with current ISO 9001 and ISO 27001 standards preferred
• Familiarity with 21 CFR Part 11, FDA, and GCP requirements
• Basic understanding of CROs and scientific & clinical data/terminology, & the drug development process