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http://biotech.fyicenter.com/jobs/99897915_Clinical_Safety_Reporting_Engineer.html
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Date: 09-Nov-2006



Clinical Safety Reporting Engineer

DUTIES & RESPONSIBILITIES

· Responsible for supporting pharmaco-vigilance activities through
timely delivery of quality reports from Millennium's
pharmaco-vigilance system: · Preparation of all listings and
tabulations in support of Similar Event Analysis, NDA Periodic, PSUR,
and ASR · Create and produce signaling reports to analyze the safety
profile of marketed and investigational drugs · Generate reports for
ad-hoc investigations using Oracle Reports.

· Perform frequency analyses on adverse events

· Analyze data quality and consistency

· Participate in data analysis, signaling, trending and development
of metrics

· Develop and implement reporting solutions. Leas or participate in
the analysis, design, build, and testing of reports while working
directly with end-users, IT, and technical members of the clinical data
management and pharmaco-vigilance

· Interface with IT, vendors, consultants, and pharmaco-vigilance
staff in the design, development, enhancement, testing, validation and
implementation of new or enhancement of existing systems

· Perform operational and performance qualification validation prior
to the implementation of new or system enhancements

· Write or modify SQL scripts or write programs that may be required
for system customization

· Key participant in MedDRA upversioning activities

· Maintain the data dictionary for the pharmaco-vigilance system

· Participate in the development of coding conventions, SOPs,
guidelines and other related coding documentation

QUALIFICATIONS · At least 5 years experience in data management or
pharmaco-vigilance

· Familiarity with pharmaco-vigilance systems, preferably Argus

· Proficiency in PL/SQL programming and reporting tools

· Experience with MedDRA dictionary structure and hierarchy ·
Familiar with GCP, ICH, and FDA regulatory requirements as they apply
to pharmaco-vigilance data management · Familiarity with computer
systems validation principles and 21 CFR part 11 · Knowledge of
medical terminology and clinical trials data structure · Formal
quality control and system validation experience · Demonstrated
flexibility and ability to manage multiple deliverables on concurrent
timelines · Ability to adapt to a fast-paced work environment ·
Demonstrated high-level of accuracy and efficiency and ability to
multitask · Excellent organizational skills with great attention to
detail · Strong problem-solving skills · Excellent verbal and
written communications skills · Ability to work independently as well
as collaboratively in a team environment



Thank you,
BioTech FYI Center
http://biotech.fyicenter.com/