Pharmacovigilance Data Manager Require at Novartis
Post: Pharmacovigilance Data Manager
Job Description:
Apply scientific and computing skills to retrieve data and develop/prepare outputs from the safety database to support the analysis of drug safety related tasks.
Major Activities (Describe main activities)
1. Understand and translate data retrieval need into query request, create query criteria, retrieve data from the safety database and provide the results to IMSstaff or external line functions .
2. Perform QC check on data retrieved; Identify errors/inconsistencies in outputs and resolve them or initiate their resolution.
3. Generate regulatory reports, standard reports, tabulations, graphs and retrievals in prepara-tion for regulatory submission
4. Lead, coordinate or support data management initiatives as and when needed.
5. Testing and validation activities to support operational change requests andIMS IT projects.
6. Development, testing and validation of new reports and/or cognos cubes for the IMS STAR data query and analysis tool.
7. Electronic unblinding of relevant SAEs from clinical trials in the safety database, as appropri-ate.
Apply scientific and computing skills to retrieve data and develop/prepare outputs from the safety database to support the analysis of drug safety related tasks.
Major Activities (Describe main activities)
1. Understand and translate data retrieval need into query request, create query criteria, retrieve data from the safety database and provide the results to IMSstaff or external line functions .
2. Perform QC check on data retrieved; Identify errors/inconsistencies in outputs and resolve them or initiate their resolution.
3. Generate regulatory reports, standard reports, tabulations, graphs and retrievals in prepara-tion for regulatory submission
4. Lead, coordinate or support data management initiatives as and when needed.
5. Testing and validation activities to support operational change requests andIMS IT projects.
6. Development, testing and validation of new reports and/or cognos cubes for the IMS STAR data query and analysis tool.
7. Electronic unblinding of relevant SAEs from clinical trials in the safety database, as appropri-ate.
Candidate Profile:Education (minimum/desirable): Life science, biomedical or computing degree (B.Pharm, B.Tech, B.E, M.Sc, MCA or Computer Science Graduate)
Languages: English
Experience/Professional requirement:
• Experience of retrieving data from relational databases or SAS datasets.
• Experience of working on IT projects, GXP and validation requirements.
• Programming Skills
• Preferred - 2 years experience in clinical or safety data management or closely related areas of responsibility
• Preferred - Medical terminology and MedDRA knowl-edge.
• Preferred – Report/Cube development experience. (TOAD or Cognos an advantage).
Languages: English
Experience/Professional requirement:
• Experience of retrieving data from relational databases or SAS datasets.
• Experience of working on IT projects, GXP and validation requirements.
• Programming Skills
• Preferred - 2 years experience in clinical or safety data management or closely related areas of responsibility
• Preferred - Medical terminology and MedDRA knowl-edge.
• Preferred – Report/Cube development experience. (TOAD or Cognos an advantage).
Additional Information:
Experience: 2 years
Location: Hyderabad
Education: B.Pharm, M.Sc
Industry Type: Pharma/ Biotech/Clinical Research
Functional Area: Medical
Division: Pharma
Job Type: Full Time
Employment Type: Permanent
Job ID: 80473BR
End Date: 11th May, 2011
Experience: 2 years
Location: Hyderabad
Education: B.Pharm, M.Sc
Industry Type: Pharma/ Biotech/Clinical Research
Functional Area: Medical
Division: Pharma
Job Type: Full Time
Employment Type: Permanent
Job ID: 80473BR
End Date: 11th May, 2011
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posted by National College Of Pharmacy @ 03:55
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