Sebila Rustempašić

I’m a detail-oriented Senior Pharmacovigilance Associate with three years of experience in ICSR management, case processing, and pharmacovigilance compliance. I bring a strong sense of duty, high working standards, and an ability to stay organized while managing multiple priorities in fast-paced, high-stress environments.

At PrimeVigilance – Ergomed d.o.o, I served as an SME and primary point of contact for clients, project directors/managers, partners, and reporters. I performed regulatory assessment and PADER submission, supported cross-reporting, and delivered final reports following FDA submission.

I’m trusted to handle end-to-end safety workflows: SAE and SUSAR management (including unblinding and clinical trial reconciliation), triage, medical assessment of incoming ICSRs, query generation, and quality control in local databases. I also supported department compliance monitoring, CAPA identification and follow-through, DSURs and aggregate reporting, and coding using MedDRA and WHO standards, while working in line with GCP/GMP/GLP/GVP and SOPs, including GDPR data privacy practices.

Beyond pharmacovigilance, I’ve led qualitative data research projects as a Project Manager—coordinating recruitment timelines, in-depth interview logistics, and quality checks on transcripts and records. I also volunteer as a Doctor of dental medicine, which strengthens my patient-centered communication and clinical attention to detail.