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http://biotech.fyicenter.com/jobs/99897915_Clinical_Safety_Re****ting_Engine=
er.html
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Date: 09-Nov-2006
Clinical Safety Re****ting Engineer
DUTIES & RESPONSIBILITIES
=B7 Responsible for sup****ting pharmaco-vigilance activities through
timely delivery of quality re****ts from Millennium's
pharmaco-vigilance system: =B7 Preparation of all listings and
tabulations in sup****t of Similar Event Analysis, NDA Periodic, PSUR,
and ASR =B7 Create and produce signaling re****ts to analyze the safety
profile of marketed and investigational drugs =B7 Generate re****ts for
ad-hoc investigations using Oracle Re****ts.
=B7 Perform frequency analyses on adverse events
=B7 Analyze data quality and consistency
=B7 Participate in data analysis, signaling, trending and development
of metrics
=B7 Develop and implement re****ting solutions. Leas or participate in
the analysis, design, build, and testing of re****ts while working
directly with end-users, IT, and technical members of the clinical data
management and pharmaco-vigilance
=B7 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
=B7 Perform operational and performance qualification validation prior
to the implementation of new or system enhancements
=B7 Write or modify SQL scripts or write programs that may be required
for system customization
=B7 Key participant in MedDRA upversioning activities
=B7 Maintain the data dictionary for the pharmaco-vigilance system
=B7 Participate in the development of coding conventions, SOPs,
guidelines and other related coding do***entation
QUALIFICATIONS =B7 At least 5 years experience in data management or
pharmaco-vigilance
=B7 Familiarity with pharmaco-vigilance systems, preferably Argus
=B7 Proficiency in PL/SQL programming and re****ting tools
=B7 Experience with MedDRA dictionary structure and hierarchy =B7
Familiar with GCP, ICH, and FDA regulatory requirements as they apply
to pharmaco-vigilance data management =B7 Familiarity with computer
systems validation principles and 21 CFR part 11 =B7 Knowledge of
medical terminology and clinical trials data structure =B7 Formal
quality control and system validation experience =B7 Demonstrated
flexibility and ability to manage multiple deliverables on concurrent
timelines =B7 Ability to adapt to a fast-paced work environment =B7
Demonstrated high-level of accuracy and efficiency and ability to
multitask =B7 Excellent organizational skills with great attention to
detail =B7 Strong problem-solving skills =B7 Excellent verbal and
written communications skills =B7 Ability to work independently as well
as collaboratively in a team environment
Thank you,
BioTech FYI Center
http://biotech.fyicenter.com/
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