Stefan Mrkonja Email & Phone Number

Belgrade, Rs

Belgrade, Rs

Belgrade, Serbia

• Medical-scientific evaluation of development and in-licensing projects as well as • product opportunities within the scope of Specialty Pharmaceuticals: assessment of therapeutic use, medical need, indication areas, benefit-risk profile, pre-clinical development, patient population, orphan drugs, competitor products• participation in due diligence projects• collaboration with internal functions like portfolio management, regulatory and/or clinical affairs, pharmaceutical development• Support in responding to medical enquiries from patients, physicians, pharmacists

Belgrade, Serbia

• Reviewing and approving post-marketing Individual Case Safety Reports (ICSRs) and Serious Adverse Event (SAE) reports occurring in clinical trials for medical/causality assessment. Review includes coding, seriousness assessment, Company causality and comment, listedness/expectedness and follow-up questions. Including completion of all required supporting documentation such as trackers.• Reviewing literature screening search strategy • Reviewing articles to determine if they contain ICSRs/ SAEs related to the relevant Medicinal Product or other safety related findings• Reviewing database outputs • Performing activities in the scope of ICSR management unit within agreed extent and timeframe (including, but not limited to):- Processing Individual Case Safety Reports (ICSRs) from all sources in compliance with applicable regulations and in accordance with client-specific requirements and timelines-MedDRA and WHO coding

Belgrade, Serbia