Pharmacovigilance Specialist

International original pharmaceutical company is looking for Pharmacovigilance Specialist.

Key responsibilities:

• Monitor the regulatory environment and ensure legislation compliance in Ukraine. Monitor regulatory environment and ensure full compliance with relevant legislation and internal SOPs. To monitor local Health Authorities requirements on pharmacovigilance of marketed products in Ukraine and Moldova and products in clinical trials in Ukraine on monthly basis;
• Execution of local contact person of QPPV role in Ukraine;
• Daily Check of GS-list for relevant SAEs and submission to the local HA  in Ukraine and Moldova. Timely update local GS Tracker for each report. 
• To ensure PSUR submission for marketed products to local HA according to local regulation;
• Weekly review of scientific literature, external websites for safety information;
• Submission of safety data reports for clinical products (SUSAR, DSUR, Periodic SUSAR) within required timelines to Health Authorities in Ukraine and IRB-IECs. Preparation of the initial safety packages for the new trials;
• Timely reporting of Customer complaints to Customer Complaint Center. Logging for customer contacts;
• To provide training on safety issues for internal and external stakeholders;
• To be responsible for safety issues in frame of the Regulatory processes of registration, re-registrations, variations, to prepare the analysis of safety use of the products;

Profile of the person:

• Higher pharmaceutical/medical education mandatory 
• qualification to handle PV aspects according to local legislation
• 3-4 years of experience in PV 
• English Upper Intermediate
• Attentive to details