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Pharmacovigilance Data Manager

Secunderabad, Telangana
Job Code:
  • Biotechnology & Science
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Job Details

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.
Degree: M.Pharm. (Pharmacy) | M.Sc. (Science) | MD/ MS (Medicine)

Additional Degree: B.Pharm. (Pharmacy) | B.Sc. (Science) | MBBS

Experience: 3-4


Data Management/ Statistics | Documentation/ Medical Writing | Quality Assurance/ Control
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