JANET M. HALLAS

*** ***** ** ? Libertyville, Illinois 60048

accg7x@r.postjobfree.com ? 847-***-**** (H) ? 847-***-**** (C)

SUMMARY OF QUALIFICATIONS

Dependable, organized and hard-working Regulatory Reporting

Specialist/Compliance Safety Specialist professional with excellent skills

and background working for Pharma companies:

? Expertise working

with FDA Regulatory submissions from project initiation through

completion including periodic and annual updates and 15 day and 7

day expedited reports for post marketed and IND products.

? Knowledge of all

aspects of Regulatory/Pharmacoviglance report guidelines including

assembly and distribution of periodic reports and safety updates.

Able to complete multiple projects within stringent timeframes.

? Proficient with

ARISg (software used to collect adverse event information)

Microsoft Excel, Microsoft Word, Adobe Acrobat professional and the

report generator AQT (A Quick Tool).

? Solid communication

skills and possess report generator skills essential for data

collection and summary.

? Possess a degree in

Information Technology.

EXPERIENCE HIGHLIGHTS

TAKEDA GLOBAL RESEARCH and DEVELOPMENT - Lake Forest, Illinois

Pharmacovigilance Data Coordinator, May 2008 to Present

Contributing member of the Pharmacovigliance department responsible for

collection of drug safety information, evaluation and assessing safety

outcomes according to FDA reporting requirements. Utilize broad skills in

AQT, ARISg and Adobe Acrobat to generate reports used for evaluation and

submission to the FDA. Communicated with supervisors and team members to

identify and complete project objectives on schedule and according to FDA

guidelines and timelines.

TAP Pharmaceuticals - Lake Forest, Illinois

Regulatory Report Specialist, June 1990 to May 2008

Contributing member of the Medical Services department responsible for

collection of drug safety information, evaluation and assessing safety

outcomes according to FDA reporting requirements. Utilize broad skills in

ARISg, Adobe Acrobat, Microsoft Excel and MicroSoft Word to generate

reports used for evaluation and submission to the FDA. Communicated with

supervisors and team members to identify and complete project objectives on

schedule and according to FDA guidelines and timelines.

CAP Gemini - Westchester, Illinois

Technical Writer, February 1989 to June 1990

BAXTER - Deerfield, Illinois

Information Technologist and Programmer/Technical Writer, 1972 to 1989

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