Senior Pharmacovigilance System Architect (Argus Administrator) - US

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Senior Pharmacovigilance System Architect We are recruiting for an experienced Pharmacovigilance System Architect (Argus Administrator SME) to join our US team.

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.

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.

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.

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