- Manage and control of the pharmacovigilance workflow in Russia, Armenia, Azerbaijan, Belarus and Georgia. - Collection, processing and timely reporting to Local Regulatory Authorities and the Global Patient Safety (GPS) about all cases of adverse events in using of company production, which is registered on the territory of Russian Federation, obtained in conduction of post registered observation trials, marketing programs or spontaneous reported information by doctors/patients, including information processing, reported to the fax and auto answer of office; - Insuring, control and documenting, timely reporting the periodic safety updating reports of company drugs to the local Regulatory Authorities (in accordance with law); - Collaboration and information exchange about company production safety with national regulatory authorities, other departments (Quality control, registration and others) and service providers (if necessary); - Tracking and timely information of Global department about pharmacovigilance (PV) about all changes in local requirements for PV system; - PV Master-file updating and maintenance; - Creation and updating of current contracts about PV with functional partners of company; - communication as single contact person about PV for regulatory authorities, and also as contact person for PV inspections with 24-hours access; - functioning control of all PV system aspects including its quality assurance system; - literature sources review with aim of finding of information about company drugs medical safety; - participation in development and updating of PV standard and local operating procedures on base of Global Operating procedures and in accordance with requirements of Russian regulatory authorities, timely updating on global/local base of changes, and also appropriate archiving and systemization of functional Global, Standard and Local Operating procedures about PV; - other actions relating to PV; - job in quality assurance (QA) system: preparation and updating of SOP in PV procedures and common QA system (documentation, trainings, audits and self-inspections, change control and others); - preparation and submission of changes introduction into medical instruction for use for company preparations related to safety

- Manage collection, processing, documentation, reporting and follow-up of all adverse event reports for all Novartis products from Patient Oriented Programs, clinical trials, non-interventional studies, Spontaneous Reports, literature, etc. Transcribe, translate and enter data of all data from source documents into safety systems accurately and consistently with emphasis on timeliness and quality. - Perform reporting/submission/distribution of safety reports/updates/information (e.g. SAE, SR, IN/SUSAR, Biannual SUSAR Listing) to local Health Authorities (Russia, Armenia, Belarus, Kazakhstan, Kyrgyzstan) and/or clinical operations in cooperation with other Country Organization Departments. - Monitoring of DPA-RCA-CAPA (local quality activities) process in case processing. - Support Regionalization project. Perform collection, archiving and transferring safety-related documentation for entering cases into Safety database by Cognizant team. - Work with other local/global Patient Safety associates to ensure accurate evaluation of safety data. - Interact and exchange relevant safety information with local Health Authority, Patient Safety associates, other functional groups and third party contractor, if applicable. - Develop, update and implement local procedures to ensure compliance with Patient Safety global procedures and national requirements. - Management and maintenance of all relevant Patient Safety databases.

Химии и технологии биологически активных соединений, медицинской и органической химии, Химическая технология и биотехнология (магистр техники и технологии)