Tijana Micic

Pharmacy Specialist with proven experience in clinical trial documentation, pharmacovigilance, and medicine licensing. Adept at ensuring regulatory compliance and maintaining high standards of data integrity throughout all stages of drug development. Fluent in English with strong communication skills and proficient in Microsoft Excel for data management, analysis, and reporting.

PV Associate at Prime Vigilance (2016-04 – 2018-08)

Performed initial triage of safety notifications and processed Individual Case Safety Reports (ICSRs) using ArisG and Argus safety databases. Reviewed literature screening results to identify ICSRs and safety signals. Contributed to the preparation of aggregate safety reports (PSURs, DSURs, PADER) and supported team members in complex and high-priority cases.

Regulatory Affairs Specialist at Medicines and Medical Devices Agency (2020-12 – 2024-10)

Responsible for managing drug master data and lifecycle regulatory activities, including marketing authorizations, renewals, and variations. Issued import licenses for medicines and medical devices used in clinical trials. Reviewed clinical trial documentation and supported regulatory assessments in collaboration with clinical departments.

Applied ISO IDMP standards for the identification and classification of medicinal products. Approved the use of unregistered medicines under medically justified conditions.

Assessor of preclinical and clinical documentation as well as Clinical Trial protocols at Medicines and Medical Devices Agency (2024-10 – Present)

Experienced in evaluating clinical documentation for efficacy, safety, and benefit-risk balance of investigational drugs. Skilled in assessing clinical trial protocols, including study design, patient selection, dosing, safety monitoring, and regulatory compliance with EU and therapeutic area-specific guidelines. Proficient in preparing expert reports on preclinical and clinical data.

Pharmacist at KATARINA FARM (2016-01 – 2016-03)

Dispensed prescription medicines and sold over-the-counter products while ensuring treatment compatibility and appropriate dosing. Checked labeling and supply accuracy to maintain patient safety. Provided consultations to patients on medication use and therapeutic guidance.

Office assistant at IBA CONSULTING (2013-11 – 2015-06)

Managed calendars and coordinated events, ensuring efficient scheduling and organization. Processed expense reports and supported administrative functions by creating and editing business documents.

Pharmacist at PHARMACY BELGRADE (2013-03 – 2013-12)

Managed calendars and coordinated events, ensuring efficient scheduling and organization. Processed expense reports and supported administrative functions by creating and editing business documents.

Integrated academic studies in Pharmacy – Faculty of pharmacy (2007-10 – 2012-12)

Specialist academic studies in Cosmetology – Faculty of pharmacy (2018-11 – 2020-09)

Master in nutrition and supplementation – Faculty of medical sciences (2024-10-present)

– Valjevo Grammar School (2003-09 – 2007-06)