Senior Pharmacovigilance System Architect; Argus Administrator

Senior Pharmacovigilance System Architect 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 Eudra Vigilance regulations.
• Provides support and execution of activities related to Eudra Vigilance 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.

• 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.