Lejla Cehajic

• To prepare, submit and follow-up pricing & reimbursement approval applications and drive company pricing & reimbursement strategy. • To take responsibility for registration of products, renewals and variations in accordance with individual & business plan. • To back-up PV responsible person as required. • To take certain responsibilities in quality management. • To take certain responsibilities in promotional material review.

Leading activities for the first registrations, renewal procedures, variation submissions, drug safety reports preparation for local HAs, obtaining regular control of all imported batches, obtaining certificates for the first imported batches, continuity of regular contact with responsible from Health Authorities and wholesalers/distributors, taking care about tender's documentation and intervene importing, variation submissions, PV activities (reconciliation, literature).

All activities about first registration and renewing processes, variations, preparation of drug safety reports to BH's Drug Agency, following procedures about regular control and control of first imported batches for all medicines from Novartis portfolio, continious contact with responsible from Drug Agency and Control Laboratory of Agency.

Regulatory Affairs, Pharmacovigilance Dept., Market Access Responsible Leading role in making decisions about tenders, marketing authorization, registration procedures and support in a field of drug safety and pharmacovigilance

All required activities about registration, renewal and variations for Nycomed's registered portfolio.

Registration of medicines. Cooperation with the responsible from Health Authorities - Agency for Medicines and Medical devices, Federal Ministry of Health, Quality Control Laboratory, Institute for Pharmacology. Regular education and training for new employees about importance about Pharmacovigilance System. Creation of Art Works and Leaflets, as well as full translation of smpc and pil-texts. PSUR submission to the HA, regular activities about variations.

Full organization about subject's practical part for students. Assistant to professor. All activities about exams planning.