Abbott is a global healthcare company devoted to improving life through the development of products and technologies that span the breadth of healthcare. With a portfolio of leading, science-based offerings in diagnostics, medical devices, nutritionals and branded generic pharmaceuticals, Abbott serves people in more than 150 countries and employs approximately 73,000 people.
Main responsibilities:
Ensures local processes and procedures for Ukraine and CIS countries are in place to clearly define pharmacovigilance responsibilities within the Affiliate in line with Global SOPs and local regulations;
Maintains compliance with local agreements, including reconciliation between partner companies Compliance;
Acts as the key Affiliate contact for both internal audits and Regulatory Authority inspections;
Ensures a local tracking system is in place, to ensure timely submissions of adverse events to Abbott Global Pharmacovigilance (GPV), and of ICSRs and Periodic Reports to the Regulatory Authority;
Reports monthly compliance metrics to GPV within the required timelines;
Maintains awareness of local PV legislation;
Ensures GPV is promptly notified of any changes to relevant Local Legislation;
Co-ordinates Affiliate review and submission of periodic safety reports;
Completes monthly ICSR reconciliation with interacting departments and/or partner companies (if applicable) and acts upon any discrepancies;
Ensures any changes to Affiliate safety personnel are communicated to the Regulatory Authority (if required by national legislation), GPV and the EU QPPV (if applicable) in a timely fashion.
Main requirements:
Higher Medical education;
Experience in the field of pharmacovigilance (2-3 years);
Excellent computer skills (PowerPoint, Excel, Word);
English – Upper-intermediate;
Driver’s license;
Good team player, great communication skills, tolerance, pedantry, propensity to scientific work, fast learning.