Team Manager - PVDM [148761BR] @ Novartis, India

Responsible for the management of the assigned team within the PVDM group. - Oversees delivery of outputs and reports from the Global Pharmacovigilance database to meet the evolving demands for case management, safety surveillance, signal detection, risk management and management metrics. - Driver of delivery of reports and innovation by contributing in the implementation of new processes and development of technical solutions to optimize the efficiency in the area of Pharmacovigilance Data Management to enhance safety surveillance, case management and delivery of management metrics. - Provide efficient support to all customers in the monitoring of safety profile of all Novartis Marketed & Investigational products. Involved in providing a high level of expertise to retrieve data and prepare complex outputs from the Pharmacovigilance database to support the analysis of drug Pharmacovigilance related tasks. - Mentoring, training and delivering of high level of expertise during approval of activities to other data managers. - Identify process improvements and lead data management related activities. Support other Pharmacovigilance Data Managers and DS&E customers or other external line units by providing a high level of expertise concerning the definition and/or implementation of Complex retrievals. Perform QC check on complex data retrieved; Identify errors/inconsistencies in outputs and resolves them or initiates their resolution. Provide input and review database design, validation checks and necessary reports To ensure high quality and consistent data during retrievals. Coach, train and mentor new Pharmacovigilance Data Management personnel as appropriate. Act as the business lead for assigned DS&E data management activities. Proactively identifies opportunities for improvement and harmonization of Pharmacovigilance Data Management and DS&E business processes and proposes and implements new solutions. Involved in testing and validating activities to support operational change requests and DS&E IT projects. Assist Department Head in defining Pharmacovigilance data management strategy and guidelines in order to establish common rules for assessing adverse event reports. Assist and deputize for the Head Pharmacovigilance Data Management as appropriate. Assist Head Pharmacovigilance Data Management in writing procedural documents as appropriate.

Minimum requirements:

Life science, biomedical or computing degree with a minimum of programing experience in SQL or SAS. English - Experience in clinical or Pharmacovigilance data management or closely related areas of Responsibility. - High level experience of retrieving data from Relational databases. - At least 6 years of technical experience in clinical or Pharmacovigilance data management or closely related areas of responsibility. - Medical terminology and MedDRA knowledge. - Ability to improve and harmonize processes. - Ability to lead and deliver initiatives

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