Dear Allstat,

Please find below the latest Permanent vacancy:


Purpose of the Job:

The Global Product Safety Data/System Analyst is to provide programming and
data management expertise to support to the Global Product Safety
Organization, Program/Product Teams, Health Outcomes, Affiliates, and other
functional areas within the Company.  The Data/System Analyst will have the
following responsibilities: support the development of risk management
plans; assist in the characterization of the natural history of diseases;
develop analytic tools to support signal detection; assist in responding to
safety questions from regulators; provide data management support to
pharmacoepidemiology studies; utilize and manage large external
patient/health databases; and collaborate with external research
organizations.  
 

 
Core Tasks:

Develop high-level expertise on global issues around regulatory practices as
they relate to Global Product Safety; act as subject matter expert in the
understanding and practice of selected Global Product Safety business
practices including standard operating procedures; develop and update Global
Product Safety training tools/programs as it relates to programming and data
management; and provide programming support to Therapeutic Areas and
affiliates in Global Product Safety.

 

Support Risk Management Planning

Provide programming and data management expertise to support new product
launches and existing marketed products; partner/collaborate with both
Program/Product Teams and Global Product Safety physicians on the
development of risk management plans; provide data management support for
pharmacoepidemiology studies, work with external investigators and CROs;
manage large external patient/health databases (e.g., PCS, GPRD, and HMO) in
evaluating safety concerns. 

 

Characterize Natural History of Diseases

Provide programming and data management support to Epidemiologist,
Program/Product Teams and Global Product Safety physicians with patient
population data to understand the nature and burden of illness of various
disease/conditions for which the Company is developing new products to treat
or to prevent; support epidemiology studies to characterize disease trends,
frequencies, incidence/prevalence, co-morbidities, outcomes, risk factors
and treatments.

 

Collaboration with Internal and External Customers

Communicate effectively with internal contacts from the Affiliate offices,
legal, and other customer groups; collaborate with Program/Product Teams and
Regulatory Scientists on issues of product safety and in preparation of
responses to requests posed by regulatory authorities; support
Program/Product Teams regarding safety information requests.

 

Strategic development of analytic tools

Develop analytic tools to assess safety across clinical studies (in real
time) and for post-marketing surveillance; support the investigation for the
potential use of data mining tools for clinical trial data and spontaneous
data, partner on the development of new standardized analytic methods for
selected regulatory safety documents/submissions (e.g., PSUR, ISS, product
labels).

 

Job Requirements:      

*	A college degree and extensive experience in data management and
programming
*	Experience in managing large external patient/health databases.
*	Competent in the independent analysis of data from clinical and
epidemiology 	studies.
*	Excellent computer skills; extensive programming knowledge of SAS,
SPSS,and/or 	equivalent statistical software package.
*	Have strong oral and written communication skills, strong
interpersonal and 	leadership skills, and able to work independently
and as a team member to resolve a 	variety of drug safety issues.

 
Preferred Skills:

*	High-level knowledge of global regulations with respect to adverse
event reporting
*	High-level knowledge and understanding of Global Product Safety
policies
*	Experience utilizing large patient population databases.


 
I also have a variety of other Biometric specific vacancies available in the
UK and throughout Europe. 

Inclusive of SAS programming, Statistical, Data Management functions, please
call me for further details....

If you would like to discuss this role in greater detail or your application
/ suitability to this or further roles, please call me or email me in
confidence. If you are not available or suited to this position, please feel
free to pass my details on.

For a confidential consultation call Mathew Hogan on 0044 (0) 207 255 6665
or email your CV to [log in to unmask]


Mathew Hogan
Senior Consultant
Pharmaceutical, Biometrics & CRO Division

1st Pharma People
A Division of 1st-IT People
Tel: +44 (0) 207 255 6665
Fax: +44 (0) 207 255 6656
mailto:[log in to unmask]
<mailto:[log in to unmask]> 
www.1st-pharmapeople.com <http://www.1st-pharmapeople.com/> 
 
PLEASE NOTE: As of 31st May 2005 our office address will change to; 1st IT
People, 3rd Floor, Woolverstone House, 61-62 Berners Street, London. W1T
3NJ. As a result of this, we do have a new telephone number of 0207 255
6665. Please note our previous phone number will still work.

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