Senior Pharmacovigilance System Architect (Argus Administrator)
New
M
MMSPharmacovigilance systems
IndiaFull-TimeSenior
Salary not disclosed
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Job Details
- Experience
- Minimum of 5 years’ experience in Information Technology or similar field required.
- Required Skills
- GCPMS Office
Requirements
- College graduate in an Information Technology discipline or related field, or equivalent related experience.
- At least 5 years of experience in Information Technology or a similar field.
- Strong understanding and experience with Argus configuration and study setup.
- Strong understanding of global case processing and SAE reporting.
- Strong understanding of global clinical trial development and data.
- Expert knowledge of scientific principles and concepts.
- Proficiency with MS Office applications.
- Familiarity with 21 CFR Part 11, FDA, and GCP requirements.
- Basic understanding of CROs, scientific and clinical data terminology, and the drug development process.
- Familiarity with current ISO 9001 and ISO 27001 standards preferred.
- Hands-on experience with clinical trial and pharmaceutical development preferred.
Responsibilities
- Administer Argus Safety databases, including configuration, issue resolution, maintenance, governance, and daily support.
- Install and upgrade systems, configure reporting rules, and support E2B reporting, including Axway Gateway Interchange setup and configuration.
- Support PV and drug-safety systems and update Argus configurations and processes to align with changing Eudravigilance regulations.
- Execute Eudravigilance testing activities and perform case migrations, database transfers, file imports, and related case-processing activities.
- Lead Argus upgrades and provide administrator support for other safety databases, including ARISg.
- Update Argus coding dictionaries, including MedDRA and WHO Drug.
- Assist Drug Safety Associates with electronic submissions of serious adverse events to European agencies.
- Write Argus Safety SOPs, Work Practice Documents, and Data Entry Manuals; generate case-processing metrics and support process improvements.
- Coordinate project activities directly with clients and serve as a PV and drug-safety systems subject matter expert.
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