Maria Vass

WORK HISTORY

EDUCATION

ABOUT MARIA VASS

Global Safety Lead in clinical trials from first in man through to late stage, registration & PAES/PASS. • Over 15 years pharmaceutical global industry experience in Pharmacovigilance, Clinical Safety and Drug Development with international exposure, including 6 years as EU QPPV & Deputy QPPV. • Unique set of skills and expert knowledge in establishment of Functional Area from scratch and harmonisation of Clinical Safety and Drug Development processes across EU, USA & Asia. • International expert in innovative solutions that transform business processes globally. • Global regulatory submissions experience with successful approval of medicinal products in Europe, USA and Asia. Expertise in Company Core & regional product information documentation. • Extensive experience in advisory and pre-submission meetings with Regulatory Agencies (FDA, EMA, MHRA, BfArM, ANSM, MEB, FAMHP & PMDA). • Global lead in signal detection, benefit-risk assessment, risk management & minimisation activities with ability to recognize safety data trends & molecule targeted toxicities for developmental & post-marketing global products. • Experience in MHRA & FDA Inspections; expert in GXP audits. • Expert in establishing & managing Pharmacovigilance System Master File (PSMF). • Expert in clinical study & aggregate safety reports (CSR, DSUR, PSUR, PBRER) preparation. • Global pre- and post-marketing Clinical Safety & Drug Development experience with knowledge of EU, US and Japanese regulations. • Strategic leader of international teams with strong project & people management, problem-solving skills and ability to make complex judgment and develop innovative solutions. • International Medical Monitor experience with responsibilities for clinical safety & medical integrity of global clinical trials. • Over 25 years’ experience of working in multifunctional, multicultural, international teams with proven ability to work successfully across cultures.