Case processing activities in Argus safety database system (Book-in, Prioritization, Data Entry, Peer Review) for Initial and Follow-Up reports. Follow-up activities: requests to Health Care Professionals (HCP), investigators and consumers for obtaining additional information, clarifications and specifications as per SOPs and guidelines; interaction with local Product quality complaint group and Medical Information team. Preparation of notifications to other manufacturers for suspect concomitant drugs. Liaise with key partners, locally , and other stakeholders regarding safety data collection and data reconciliation Determine reportability of scheduled reports for Russia and CAUCAR countries, ensuring adherence to regulatory requirements. Entering of cases into Roszdravnadzor database.

Acting as a Superuser/ Local Administrator/single point of contacts (SPOC) of Clinical trial management system (CTMS) Preparation of internal and external trips (including visa process) for clinical trial monitors (CTMs), country study managers (CSMs), investigational site staff for the purpose of Investigator meetings and other business aims. Preparation of investigators’ payments (contracts, acceptance acts) Expenses reports preparation Assistance in ordering and distribution of study-related supplies and/or co-ordination of local suppliers and vendors Coordination of imported and exported study-related supplies. Work with logistic companies, preparation of documents for biological samples export Preparation of submission packages for Institutional Review Board (IRB) Reconciliation/tracking of essential documents necessary for the country-level Trail Master File to ensure timely study closure. This includes collection/retention/reconciliation of regulatory and investigator documentation, safety reconciliation, drug and non-drug supply reconciliation Acting as back-up to the SAE Responsible Co-Monitoring, if required and with appropriate oversight and training, during high volume periods (e.g. initiation visits, document reconciliation at study close-out) In-house back-up CTM coverage, as required, and with appropriate support, by temporarily assuming in-house CTM responsibilities Maintenance of Trial Master Files (TMF) on Country level for the study(s), in accordance with SOP requirements under the direction of LST Recording of meeting minutes

Preparation, collection and registration of documents for HR files, maintenance of necessary correspondence. Issuing confirmation of employment letters and making labor books copies for employees at their requests. Updating the HR database and maintenance of archives. Maintenance of the HR Department filing system. Implementation of HR Dept. current projects, including translations (from the English language) of HQ materials/correspondence, collection and editing articles for the internal newspaper. Preparation for surveys, training, etc

Assistance to HR Administrator in preparation, collection and registration of documents for HR files, maintenance of necessary correspondence. Issuing confirmation of employment letters and making labor books copies for employees at their requests. Assistance in updating the HR database and maintenance of archives. Maintenance of the HR Department filing system. Providing assistance in implementation of HR Dept. current projects, including translations (from the English language) of HQ materials/correspondence, collection and editing articles for the internal newspaper. Assistance in preparation for surveys, training, etc. Providing assistance to HR Dept. collaborators in setting up meetings and arranging business trips.

Answer all incoming calls and handle caller’s inquiries if possible Re-direct calls as appropriate and take adequate messages when required Deal with incoming/outgoing mails and faxes Coordinate airport pick-ups & returns with the driver Greet and assist visitors Stationary needs