Ena Hasković Aran

- Full management of Complaints in accordance with FDA Medical Device Reporting and European Vigilance reporting requirements, as Per ISO 13485:2016 - Assessing event reports - Conducting statistical assessments and analyze trends - Collaborating with Engineers to ensure the timely assessment and resolution of Complaints - Managing customer relationships and expectations - Maintaining well-organized records following GDP - Annual and PSUR Reports - Internal and External Audits; CAPA Process

Activities related to Individual Case Safety Reports Management: Processing ICSRs from different sources in compliance with PV procedures and client’s requirements; ICSR follow up; SAE/SUSAR Management (unblinding, clinical trial reconciliation, potocol review, Safety Management plan review); MedDRA and WHO coding; Reconciliation (clinical, partners); Personal data protection; Product Quality Complaint handling and interaction with Quality Assurance; Medical Information interaction.

Working in the area of NOACs and blood thinning medicaments [Xarelto and Aspirin]; Conducting research, gathering accurate scientific and medical data and helping in creation of comprehensive documentation for these topics in Bosnian language, which were later used as basis for Health Care Professionals; Translation of various real-world evidences, case studies, articles and brochures from English to Bosnian language and vice versa; Administrative work, basic sales analysis and graphic representation.

Shadowing work of head pharmacist; Medical supplying and storing; Preparation of Magistral and Galenic formulation medicines; Communication, understanding and advising the patients; Usage of IT system of pharmacies in Sarajevo.

Master thesis: Development of new agonists and antagonists of cannabinoid receptors