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: 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 DS&E staff 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 preparation 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 and DS&E IT projects.
6. Development, testing and validation of new reports.
7. Electronic unblinding of relevant SAEs from clinical trials in the safety database, as appropriate.
Candidate Profile:
Education (minimum/desirable): Life science, biomedical or computing degree (B.Pharm, B.Tech, B.E, MSc, 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 knowledge.
• Preferred – Report development experience. (TOAD an advantage).
Additional Information:
Experience: 2-5 years
Location: Hyderabad / Secunderabad
Education: B.Pharm, B.Sc, M.Pharm, M.Sc
Industry Type: Pharma/ Biotech/Clinical Research
Functional Area: Development & Medical
Division: Pharma
Business Unit: Pharma - Global Development
Job Type: Full Time
Employment Type: Permanent
Job ID: 76735BR
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