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Thursday, 25 August 2016

Pharmacovigilance Data Manager

Novartis Healthcare Pvt. Ltd.
3 - 5 yrs
Hyderabad / Secunderabad

Job Description

 
- To retrieve data and prepare outputs from the Pharmacovigilance database to support the analysis of drug safety related tasks. - Uses their experience of pharmacovigilance data management to mentor and train other data managers. - Identify process improvements and lead data management related activities.

Major Accountabilities: Support DS&E customers or other external line units by providing them with retrieved data from the Pharmacovigilance database. Understand and translate data retrieval need into query request, create query criteria, retrieve data from the Pharmacovigilance database and provide the results to DS&E staff or external line functions. Generate regulatory reports, standard reports, tabulations and retrievals in preparation for regulatory submission Perform QC check on data retrieved; Identify errors/inconsistencies in outputs and resolves them or initiates their resolution. Train and mentor new Pharmacovigilance Data Management personnel as appropriate. To Provide Input and review of database design, validation checks and necessary reports to ensure high quality and consistent data during retrievals. Identifies opportunities for improvement of DS&E business processes and proposes and implement new solutions. Assist Department Head in defining Pharmacovigilance data management strategy and guidelines in order to establish common rules for assessing adverse event reports. Support testing and validation processes in DS&E IT projects.



Company Profile:
Novartis Healthcare Pvt. Ltd.

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. 
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