Drug Safety & Pharmacovigilance Specialist
Freelance Expert | 5+ Years of Experience Supporting pharma and biotech companies with high-quality pharmacovigilance services, regulatory compliance, and operational efficiency. 💊 Over 5 years of experience 🤝 Now available as an independent external collaborator
Kompetencije
Usluge
Certifikati
Radno iskustvo
Pharmacovigilance Officer & Team Lead
Primevigilance d.o.o. Zagreb | Siječanj 2023 – Siječanj 2024
Leading a team responsible for ICSR case processing across multiple projects Ensuring compliance with regulatory timelines for expedited and periodic submissions Managing ICSR reconciliation activities with business partners Supporting DSUR preparation and overall PV operations Overseeing workload distribution and team performance Acting as main point of contact for client communication related to case processing
Pharmacovigilance Associate
Primevigilance d.o.o. Zagreb | Siječanj 2020 – Siječanj 2022
Processing ICSRs from various sources (clinical and post-marketing) Performing medical coding using MedDRA and WHO dictionaries Handling follow-ups and expedited reporting to Health Authorities Performing reconciliation and initial triage of safety reports Using databases such as ArisG (v5 and v7) and Argus for case entry and tracking
Global Drug Safety Specialist
Arriello s.r.o. | Siječanj 2024 – Trenutno
Acting as a Process Owner for selected Global PV processes Managing assigned projects and ensuring timely and compliant delivery Performing TMF filing and documentation management in line with SOPs Supporting internal and external audits and regulatory inspections Providing training to team members and contributing to continuous improvement initiatives Engaging in cross-functional collaboration with QA, Regulatory Affairs, and external stakeholders Managing CAPAs and ensuring closure within timelines Participating in client meetings and supporting business development when required
Senior Pharmacovigilance Associate
Primevigilance d.o.o. Zagreb | Siječanj 2022 – Siječanj 2023
Performing quality checks of processed ICSRs Maintaining and updating Trial Master File (TMF) documentation Supporting audit preparation and participating in inspections Conducting literature screening and identifying ICSRs and other reportable safety information Supporting project management activities and line listings extraction Onboarding and mentoring new team members