Contractor - Safety Information Management Resume - Hire IT People

SUMMARY

A dynamic professional with sound Pharmacovigilance domain knowledge and 3+ years of experience in Oracle Argus Safety. Practiced in clarifying business requirements, performing gap analysis between goals and current procedures and designing process and system improvements to increase system efficiency and productivity.

AREAS OF EXPERTISE

Aggregate Reporting
Document handling
Project Management
E2b exchange monitoring
Account /access management
Training / Knowledge transfer
Data Quality & Management
Outsourcing processes
MedDRA version analysis

TECHNICAL SKILLS

Microsoft Office Word
Excel
PowerPoint
Outlook
Visio
Argus
COGNOS
SQL
MedDRA

PROFESSIONAL EXPERIENCE

Confidential, Glenview, IL

Contractor - Safety Information Management

Responsibilities:

Provide report generation support for safety database (Argus) by handling scheduled periodic reports like PSUR,DUSR, IND CTPR, NDA PADER, PBRER, SUSAR LLs, SAE worksheets in addition to adhoc search reports and ISL query reports.
Handle monthly reconciliation reports with various license partners to support Safety Data Exchange Agreements, PV agreements in place.
Generate Delayed report metrics to support root cause analysis of late reports and CAPA activities.
Manage CRF (Change Request Form)s and UAMRF (User Access Management Request Form)s.
Ensure and approve readiness between cross-functional teams and customer teams for new products/releases/upgrades for new and existing vendors.
Drafting and Execution of PQs and UAT scripts after major updates to safety database.
Support Signal detection & risk assessment activities by providing MedDRA Data impact analysis to Safety Analytics group.
Testing of various scenarios in DEV and VAL environments as a part of Issue and project tracking.

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Contractor - Safety Information Management Resume

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