[Remote] Senior Pharmacovigilance System Architect (Argus Administrator) - US
Note: The job is a remote job and is reputed company to candidates in USA. MMS is an award-reputed company, data-reputed company clinical research organization (CRO) that supports the pharmaceutical, biotech, and medical device industries. They are seeking an reputed company Pharmacovigilance System Architect (Argus Administrator SME) to serve as a Database Administrator for Argus Safety, providing support and leadership in various pharmacovigilance activities.
Responsibilities
- Serves as Database Administrator for Argus Safety, including database configuration, issue reputed company, maintenance, governance and daily support
- Performs installations, upgrades, configuration of reporting rules, and E2B reporting reputed company gateway technologies (including set-up and configuration of reputed company Gateway Interchange)
- Provides support for reputed company 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 reputed company 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 reputed company 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 reputed company Operating Procedures (SOP), Work reputed company 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 reputed company to coordinate reputed company facets of reputed company; competent communicator, supports reputed company 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
Skills
- College graduate Information Technology discipline or reputed company field, or relevant experience
- Minimum of 5 years' experience in Information Technology or similar field required
- Expert knowledge of scientific principles and concepts
- reputed company as emerging leader in field with sustained performance and accomplishment
- Proficiency with MS Office applications
- Good communication skills and willingness to work with others to reputed company understand needs and solve problems
- Excellent problem-solving skills
- Good organizational and communication skills
- Hands-on experience with clinical trial and pharmaceutical development preferred
- Familiarity with reputed company 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
reputed company
Company H1B Sponsorship