Job Title: ARGUS SME Techno-Functional Lead Consultant
Location: Milford, CT
Duration: Longterm
Mandatory Skills:ARGUS implementation / upgrade,SQL,PL/SQLAxway
Synchrony,E2B ESM
Job Description:
Min 3-6 year Argus Implementation/Upgrade Specialist in 8.x
Expert level experience in Configuration for Argus Console (Advanced
conditions, Reporting Rules, workflow, case priority, Auto Narratives,
Field validations, Configuration for common profile switches, Business
Configuration-Product/Licenses etc).
Impact assessment of the customization of the current system and
removing/moving them to new system.
Expert level experience in Data Argus data migration.
Development and execution of validation scripts (OQ/PA/IQ).
Domain- Pharmacovigilance / Drug Safety Adverse Event Reporting Systems at
Pharmaceutical
Expert level experience on modules like Argus configuration(System and
Business),Argus Interchange/ESM and custom E2b profiles including R3
Experience in Regulatory Standards like 21 CFR Part 11,ICH,GxP
Knowledge of regulatory guidelines from the Food and Drug Administration
(FDA), EMA and PMDA
Strong experience in SQL,PL/SQL
Ability to work with Product vendor and various stakeholder.
Experience in Axway Synchrony Gateway is an advantage
Experience in reports in Argus Aggregate and Periodic reports.
Essentials:
Degree at BE/B.Tech level or equivalent
Minimum 5 years of experience with product safety in a pharmaceutical,
biotech, medical device, or clinical research organization
Minimum 3 years of experience with Oracle's Argus Safety suite upgrade.
Excellent client interaction abilities
Ability to multi-task in a highly-organized manner
Demonstrable self-managing/self-motivating skills
Clear ability to operate within a team
Proven ability to deliver technical excellence even under tight deadlines
Expert PL SQL Scripting , sound knowledge of handling migration tool
Experience with E2B ESM Module of Argus
Exposure to SQL and/or PL/SQL
Familiarity with Unix and Windows
Excellent oral and written communication skills
Willingness to travel
Versatility, flexibility, and a willingness to work within changing
priorities
Ability to multi-task and work well under pressure
*Thanks and Regards,P.N.SUDHEER KUMARAqua Information Systems Inc.300 N
Pottstown Pike, Suite # 130Exton, PA 19341Office: 484-713-4226 # 106Direct:
484-485-7161Fax: 215-600-1617GTalk: recruitersudheer*
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