- Develop and define Kazakhstan PV strategy based on the framework provided by Global GPV - Ensure the establishment and maintenance of a local PV system in compliance with national/supranational regulatory requirements and applicable internal procedures and policies - Acts as local PV contact person for national Health Authority - Advocates the PV strategy to interfaces among within the company - Develops and implements with concerned other functions activities to enhance PV culture and PV Awareness activities in line with global recommendations - Ensures that the local PV system is adequtely described in the Local PV Framework and applicable local documents (e.g. PV Repository, corporate SOPs) - ICSR management - ICSR collection, local processing, follow-up, reconciliation, documentation and archiving. Reporting to the local Health Authorities in line with the local legislation - Ensures appropriate PV training of all local internal and exteranl staff - Ensures that an up-to-date Business Contingency Plan is in place - Management of local scientific literature screening - Maintains oversight/ implements Risk Management Measures as applicable, meeting internal and regulatory requirements - Prepares local periodic reports and local RMPs with country-specific format and content if needed in liaison with global PV functions - Adequately informs and involves the Country Management Team about patent safety and pharmacovigilance topics - Manages the local PV budget within the defined margins - Ensuring back-up employee has adequate preparedness and handover to take over above mentioned responsibilites

• Processes are compliant with local PV regulations and the global Sanofi group procedures are implemented, documented and followed locally. • Communicating changes in local PV regulations to Global PV unit. • Development and maintenance of the local PV System Master File is in accordance with the global standards. • Implementation and review of processes / quality documents are compliant with local PV regulations and global Sanofi group procedures. • Education and training on safety topics within the local organization are performed to include the documentation of attendees and topics covered (i.e.: PV Awareness, training of service providers and manufacturing sites). • Local compliance metrics are generated and deviations are managed, including Root Cause Analysis (RCA) & Corrective Actions Preventive Actions (CAPAs) implementation and related tracking activities (ICSRs/ PSRs/ HA queries). • PV requirements for local activities around PSP/MR Programs and digital media are implemented adequately. • Potential critical deviation or major systemic deviations are escalated to the Quality Risk Manager of the concerned unit. • Oversight of local PV activities is conducted through completion of periodic reports and details of this oversight are provided to Global PV unit. • Supports the CSL in the organization of a PV Operating system ensuring that: • PV data is timely reported to the PV unit and handled appropriately. Continuously monitor and review incoming calls, mails to identify ICSRs and other safety information needing reporting to GPV, HAs and partners if applicable. Ensuring case documentation completeness by appropriate communication with HCP and with consumers. • Procedures relating to the interface with local functions such as Medical Information, Medical, Clinical Study Unit, Marketing, Quality, Marketing (e.g. monitoring of social media, Customer Services, Training, etc.) are in place to guarantee the timely detection and transmission of PV data to the local PV unit. • Local periodic reports are handled appropriately, including PSRs and periodic reviews to comply with GPV Quality Documents (QDs/SOPs) and local regulatory PV requirements. Contributes together with GPV to the planning for periodic safety reports.

• Working with foreign individual case safety reports (ICSRs) - timely local/foreign ICSR data processing and submission to Health authorities and transferring data to Global Pharmacovigilance in accordance with local legislation and global quality documents requirements. • Timely submission to Health authorities of periodic safety reports in accordance with local legislation and global and local quality documents requirements, monitoring PSRs submission schedule and assisting with filling trackers. • Timely submission to Health authorities of risk management plans with local legislation and global and local quality documents requirements. • Checking for ADR/AE of Sanofi products published in the medical literature and Health authorities sites on weekly basis during whole internship. • Receipt of incoming calls and Pharmacovigilance information via Pharmacovigilance phone hotline.