On the manager position I am responsible all pharmacovigilance activities: • Serve as EAEU QPPV and PV subject matter expert for internal audits and EAEU regulatory inspections • Ensure that PV activities and procedures are maintained in compliance with all EAEU and global regulations • Communication with CDS ( Central Drug Safety) • Collection and forwarding of AE/ADRs to CDS, including requests for follow up information according to timelines laid out in the applicable SOP and local regulations • Translation and submission of PSURS and RMPs • Collectioin and providing safety relevant information on trials, PSPs, market research programs, patient named programs to CDS • Local implementation of risk minimisation measures • Local implementation of corporate PV SOPs • Providing content information relevant for the PSMF, e.g. in quarterly compliance reports • Provision of local literature search and documentation thereof • Training of local personnel • Receipt and forwarding of health authority communication to CDS • Preparation of CAPAs for audit findings and process deviations • Monitoring of timeliness of expedited reporting, PSUR submission and PV training completion • Local regulatory intelligence, knowledge of the local regulation and their impact on the local processes. Communication on regulation changes to CDS • My achievement is I created in the company the first local version of Pharmacovigilance system master file (PSMF)

Responsible for day-to-day adverse experience case management within the countries covered by the country operation including case intake and follow-up activities in accordance with Global Safety procedures. Responsible for PSUR submissions in the countries in accordance with Global Safety procedures and health authority requirements. Responsible for the reconciliation of adverse events reports received from other GSK operating units (e.g., Quality Department, Medical Information, etc.) and contractual partners, as applicable. Medical and scientific articles review to find out adverse events. Responsible for being compliant with local PV regulations, GSK policies and procedures and Global Safety procedures at the country level. Coordinate the development local Third Party Agreements with PV implications. Review local service provider agreements, co-distribution, co-marketing, in-licensing contracts to ensure PV roles and responsibilities are defined. Ensure the SDEAs are implemented locally, in close cooperation with the GPV. Creating and provision of PV-training to customer facing and non-PV staff, distributors / vendors / business partners in the countries within scope. My achievement is successful development and sure implementation PV activities in the established pharmacovigilance system of worldwide pharmaceutical company. Acquired knowledge of legislation and international guidelines, the regulatory environment.

All responsibilities of Сlinical study manager (described below) plus functionality pharmacovigilance specialist such as: receipt, investigation and collection of human safety information; entry this information into the internal database; reporting to regulatory authorities of identified safety information in accordance with corporate procedures and regulatory requirements. Creation and maintenance of PSUR (Periodic Safety Update Report), RMP (Risk management plan), DSUR (Development Safety Update Report); timely submission it to Regulatory Authorities, Investigators and Ethics Committees if required. Provide other pharmacovigilance activities, including Local Signal Detection, oversight of risk management plan implementation, interaction on safety issues, pharmacovigilance in clinical trials, maintenance of pharmacovigilance quality system and local pharmacovigilance agreements. Provision information on request for Regulatory Authorities Creating and provision of Pharmacovigilance (PV) training for all employees. Participation in PV audits and inspections for products Implementation of quality management system in Pharmacovigilance processes for products (self-inspections, risk identification, CAPA creation and management). My achievement is I created in the company the first version of Pharmacovigilance system master file (PSMF) and 12 Pharmacovigilance SOPs; 5 RMP for prescription medicine, 7 PSUR, 3 DSUR. Improved company Pharmacovigilance system in accordance to Good Pharmacovigilance practice.

Main accountabilities: manages assigned trials throughout their duration; contacts CROs, collects budgets proposals, summarizes & presents to Management team; work closely with corporate Regulatory Affairs and the markets to identify the local clinical requirements; review study protocols, clinical expert reports and any other clinical documents requested for the registration purposes; audit of the clinical part of the dossiers & related modules. Conducted site co-monitoring visits to ensure clinical aspects of study were carried out in accordance with the protocol and Good Clinical Practice (GCP) guidelines. I also was responsible for: providing medical information support to Regulatory Affairs, marketing department and other company divisions; conducting medical and ethical expertise of marketing campaigns and promotional materials, produced/ delivered locally; providing medical input into brand/product strategy; contributing to feasibility process in R&D studies; medical and scientific articles review. My achievement is I could build a good team and I enjoy working with the people. During my time with the company I successfully conducted 4 clinical trial projects (2 studies III phase, 1 study I phase, 1 study bioequivalence).

Responsibilities and tasks: all aspects of monitoring centres for clinical research, including routine monitoring, initiation and close out visits for clinical research centers; maintenance and support of clinical study documentation, writing study reports. Performing regular trainings for investigator team. Correspondence and phone talk. Operation with IMP:acceptance IMP delivery, distribution IMP to the clinical centre according sponsor and investigators request, receiving IMP returns and distraction procedure. My achievement is I failed none of the 15 projects I was responsible for.

Responsibilities and tasks: poisons components and toxins determinations to avoid fatal results of different diseases using the such methods as thin-layer chromatography, gas chromatography,gas chromatography with mass-spectrum, high-performance liquid chromatography, biochemical analysis, immunoenzyme analysis. Achievement: got good practice in using complex medical equipment.

Responsibilities and tasks: filled customer prescription orders. Contacting patients to help with over-the-counter products. Achievements: number of customers increased on 20%. I acquire in-depth knowledge in various prescription and over-the-counte drugs.