Ensuring high quality clinical trial data review/insights and analysis as directed by the integrated clinical trial team. Perform high quality clinical data review and identify clinical data insights through patient level review and trends analysis, supported interim database lock analysis ( iidbl ), snapshot activities and facilitated resolution of clinical data issues. Collaborate with relevant line functions to enhance the quality of clinical data review/insights with an emphasis on subject safety and eligibility, data integrity, trend identification, analysis and remediation, and identification of cases for medical review. Contribution to the development and updating of the data quality plan modul and clinical review tracker in studies, ensuring that protocol, level deviations, eligibility criteria, study assessments other aspects of the protocol are implemented consistently across the study. In collaboration with relevant line functions contribute to the development of study, related documents, including patient summary and patient profile

Ensure pv case compliance, meet icsr compliance targets, including internal routing timelines : collecting, monitoring, reporting, submission, archiving, submission of safety information ( susars/ dsurs/ psurs/ eu rmps ) to the local health authority ( ha ), ethics committee ( ec ), investigators. Management of pv literature search. Pv training process for local staff ( on boarding for newcomers and refreshing 1/year ) and vendors. Pv reconciliation with local staff and vendors, quality control ( qc ) : qc in pmr, psdmp. Qc translation, qc with vendors. Lead on country level in all pv aspects for renewal/ variation submission processes by labeling preparation and updating ( safety related parts ) in closed cooperation with ra and medical affairs ( ma ) colleague, negotiation and resolving of safety issues arising during renewal/ variation submission processes. Interaction with the ha, ra, gpv. Ensure pv compliance in patient support and disease management programs ( psdmp ) activities on country level by conducting of pv training in scope of psdmp for local staff and vendors and following pdmp reconciliation process. Risk minimization activities, conducting/ participating in local safety management teams ( smt ), eu rmp submission to the ha, implementation on country level of additional risk minimization activities. Medical information management activities, mi management ( ma team of 7 medical advisors ), sop responsible person ( creation/ updating ), mi training for internal staff and vendors, implementation on country level of mi databases : irms and miidas

Pharmacovigilance activities, implementation of pv activities according to global/ local sops/oms, conducting of pv training for internal staff on regular basis ( refreshing and for newcomers ), for investigators ( non, intervention studies ) and for vendors, pv lead for renewal/ variation submission processes : preparation of pv files for submission to the ha, communication with local ha and negotiation of pv issues arising during procedure. Responsible for creation of local annex to core rmp. Responsible for short labeling preparation, submission of safety information ( susars, psurs/ dsurs/ core rmps ) to the ha, local ethics committee, investigators, pv support to belarus ( submission of safety, related information to the local ha, support with global databases ) . Medical information ( mi ) activities, creation and implementation of local mi database : creation of template for local medical queries and responses. Management of appropriate documentation, creation and updating of local sop on mi, conducting of mi training to internal staff and vendors, responsible for implementation of international request management system ( irms ) database in ukraine, irms superuser for ukraine, belarus, georgia, armenia., 3, chair of family medicine

Conducting of clinical trials in accordance with requirements of study protocol patient selection conducting of visits documentation of visit ( papers, e, crf, ivrs ) positive results of audit conducted by sponsor ( france)