Ivana Vukić

Supports the organization and maintenance of the PV compliance system with metrics within the pharmacovigilance department. Subject matter expert by providing high standard of quality guidance, advice and support on PV regulation/GVP compliance matters. Duties: Regulatory inspection preparation and inspection handling. The development and improvement of quality management system. Project and program management in process improvements projects.

The role is accountable for the management of all drug safety-related activities concerning Regulatory Authority inspections and audits, as well as their resolution and follow-up.

Ensuring oversight over the compliance, consistency and quality of pharmacovigilance processes by performing deviation investigations, collecting, analysing and reporting on metrics, and driving continuous improvement of the PV System.

Performing duties of the Qualified Person for Pharmacovigilance for the company during the QPPV’s one-year absence. Development of pharmacovigilance system and procedures to improve the quality and efficiency of the company’s pharmacovigilance system. Acting as the contact person for regulatory purposes for the Croatian agency from March 2013 and as Responsible Person for medical device vigilance, from May 2016.

Responsible for EudraVigilance (EV) management, i.e. maintenance of EV account and the Art.57 database, for multiple clients. Maintaining an up-to-date global database on all current pharmacovigilance guidelines in post-marketing and clinical trials and providing regulatory advice and training to colleagues within the company. Providing support for Regulatory Manager on a global scale.

Accountable for setting up global literature screening processes within the company and providing the local support to managers at headquarter level. Awarded high performance scores by my supervisors for my work in setting up new processes for the company.