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Posted: Saturday, July 22, 2017 12:02 AM

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Description

Senior PVRM Systems Ops Associate/Shire Development, LLC/Lexington, MA

Duties:
Perform duties of an administrator of the Shire Global Safety System (SGSS); Manage the business aspects of the SGSS, including maintenance, change request, documentation, system security reporting rules, configuration and data migration; Perform reporting and query activities of SGSS through metric data compilation & Advanced Conditions, standard queries set-up and reporting tool use; Submit expedited reports to Regulatory Authorities and business partners globally according to reporting timelines; Perform validation, implementation, maintenance of IT computer systems; Identify new systems, systems enhancements, software to benefit PVRM.

Requirements:
Bachelor’s degree in Health Science, Pharmacy, or Chemistry plus two years in job offered or two years as Senior Associate, Validation Analyst or similar in pharmacovigilance safety database maintenance, configuration, custom procedures, and reporting.

Skills required: Argus safety suite (Safety, Insight, Affiliate, Argus J, Interchange), ICH E2B standards and maintenance of E2B gateway using Cyclone; SQL to create customized reports; detailed knowledge of Oracle based systems and expedited/periodic reporting tools; MedDRA design and implementation; Advanced configuration of adverse event systems.

40hrs/week; 9am-5pm

How to Apply
Please submit resume via email to globalmobility@shire.com

Contact

Name
Kenneth Brown

Job Title
Global Mobility Lead

Address
95 Hayden Avenue, Lexington, MA 02421

Email
globalmobility@shire.com

Job Location

Company Name:
Shire

Job Location:
650 E. Kendall Street
Cambridge, MA 02142

Job Specs
Duration: Full-Time, over 150 Days
Shift: First
Per Diem Position: No
Work Hours: 9:00 AM To 5:00 PM
Hours Per Week: 40
Union Position: No
Apprenticeship : No

• Location: Boston

• Post ID: 42987708 boston
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