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Requirement for Safety System Expert At Novartis

Posted June 23, 2011 · 6 - 10 Years

Organization

A global healthcare leader, Novartis has one of the most exciting product pipelines in the industry today. A pipeline of innovative medicines brought to life by diverse, talented and performance driven people. All of which makes us one of the most rewarding employers in our field.

Role

Designation     Safety System Expert (Pharmacovigilance System & Data Management)

Job Description     

Apply scientific and computing skills to maintain drug safety related systems and to develop sustaining solutions to meet the

evolving needs of DS&E.

Major Activities (Describe main activities)

 Analyze, Collect, Test, Implement, and Maintain safety database configuration changes functions from DS&E and External

line functions.

 Perform QC check on configuration changes; Identify discrepancies between the request and the implementation and resolve

them or initiate their resolution.

 Coordinate, Train, Implement DS&E IT projects and follow through the full project life cycle.

 Develop user requirement, functional specifications and propose solution for unmet safety system business needs

 Understand DS&E Processes to support process improvement initiatives.

 Perform the role of first line operational support for safety database users.

 Provide system administration support for central DS&E applications as appropriate

 Support testing and validation processes in DS&E IT projects

 Develop, provide support to create complex specialized reports from DS&E systems as appropriate

 Coach, train and mentor new Safety Systems Expert, PV Data Management personnel as appropriate.

Desired Profile     

 Experience and working knowledge with a safety database.

 Experience of retrieving data from relational databases or SAS datasets.

 Experience of working on IT projects, GXP and validation requirements.

 Programming Skills.

 Preferred- 4 or more years of experience in Pharma-IT

 Preferred – 2+ years experience in managing safety database.

 Preferred - Medical terminology and MedDRA knowledge.

 Preferred – Drug Dictionary Management System knowledge.

 Preferred – Hands on Data warehouse project experience.

Experience     6 - 10 Years

Industry Type     Pharma/ Biotech/Clinical Research

Role     Software Developer

Functional Area     IT-Other

Education     UG - B.Pharma - Pharmacy,B.Tech/B.E. - Any Specialization,BCA - Computers

PG - M.Pharma - Pharmacy,M.Sc - Any Specialization,M.Tech - Any Specialization,MCA - Computers

Location     Hyderabad / Secunderabad

Keywords     pharmacovigilance data management, SAS programmer , Clinical data management, Safety Systems Expert, Safety

database

Contact     Mr/Ms

Website     http://www.novartis.com/

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