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Novartis Invites Safety System Expert (Pharmacovigilance System & Data Management)

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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 them one of the most rewarding employers in their field.

Post: 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)
1. Analyze, Collect, Test, Implement, and Maintain safety database configuration changes functions from DS&E and External line functions.
2. Perform QC check on configuration changes; Identify discrepancies between the request and the implementation and resolve them or initiate their resolution.
3. Coordinate, Train, Implement DS&E IT projects and follow through the full project life cycle.
4. Develop user requirement, functional specifications and propose solution for unmet safety system business needs
5. Understand DS&E Processes to support process improvement initiatives.
6. Perform the role of first line operational support for safety database users.
7. Provide system administration support for central DS&E applications as appropriate
8. Support testing and validation processes in DS&E IT projects
9. Develop, provide support to create complex specialized reports from DS&E systems as appropriate
10. Coach, train and mentor new Safety Systems Expert, PV Data Management personnel as appropriate.

Candidate 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.

Additional Information:
Experience: 6-10 years
Education: B.Pharm, M.Pharm, M.Sc, B.Tech, M.Tech
Industry Type: Pharma/ Biotech/Clinical Research
Functional Area:
Division: Pharma
Job Type: Full Time
Employment Type: Permanent
Job ID:
End Date: 24th July, 2011

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