Raluca Stati

Background

About Raluca Stati

Experienced pharmacist with over 13 years in the pharmaceutical industry, specializing in pharmacovigilance, medical writing, management, and scientific research. Dedicated to ensuring patient safety through effective pharmacovigilance system management, regulatory compliance, and the authoring of key regulatory documents, including clinical overviews, Risk Management Plans (RMPs), and Periodic Safety Update Reports (PSURs). Proven leadership in managing pharmacovigilance teams, preparing for inspections and audits, and optimizing Standard Operating Procedures (SOPs), Working Instructions (WIs), and the Pharmacovigilance System Master File (PSMF). Strong foundation in scientific research and analytical thinking, supporting medicinal product development and safety monitoring. Passionate about collaboration, regulatory excellence, and advancing public health initiatives. Skills: • Pharmacovigilance Management: Adverse event reporting, RMPs, PSURs, ICSRs management, EVDAS, xEVMPD, oversight of pharmacovigilance systems, collaboration with Legal Department in preparing SDEAs and other PhV contractual agreements, compliance with GVP. • Departmental and Project Management: Leading teams, coordinating complex projects, managing inspections and audits, implementing CAPAs, project coordination. • Regulatory Medical Writing: Clinical overviews, clinical summaries, addendums to clinical overviews, RMPs, regulatory submissions. • Procedural documents writing: SOP/PSMF writing. • Scientific Research: Data analysis, quality control, scientific writing, research project management. • Community Pharmacy Management: Dispensing medications, patient counselling, inventory management, laboratory-prepared medicines, team supervision. • Software Proficiency: Microsoft Office, EudraVigilance