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Clarissa Leite Santos

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About Member

Bio

I am a Pharmacist with over 13 years of experience in Pharmacovigilance and Regulatory Affairs, currently working as a Senior Pharmacovigilance and Technovigilance Analyst at Fundação Butantan. My expertise includes drug safety, vaccine surveillance, safety database management, regulatory compliance, and quality processes. I hold postgraduate degrees in Regulatory Affairs and in progress in Research and Development of Drugs and Biopharmaceuticals. I also serve as a trainer and instructor in pharmacovigilance-related courses, with practical experience in MedDRA and WHODrug dictionaries, safety database administration, and system validation. Throughout my career, I have worked in multinational pharmaceutical companies and public health institutions, gaining experience in safety data processing, case management, reconciliation, literature monitoring, audits, regulatory inspections, and interoperability of pharmacovigilance systems. My professional goal is to contribute to the strengthening of pharmacovigilance processes, focusing on data quality, compliance, innovation, and training to improve patient safety outcomes.

Education

  • unileya
    Degree Postgraduate
    Field of Study Specialization in Drug and Biopharmaceutical Research and Development
    Start Date 01/2025
  • Instituto Federal de Educação Ciência e Tecnologia Goiano
    Degree Postgraduate
    Field of Study Regulatory Affairs Specialist, contributing to drug safety and clinical research compliance
    Start Date 01/2011
    End Date 01/2013

Experience

GG

DRUG SAFETY SPECIALIST

Grünenthal Group (Germany) •

01/2020 – 01/2021 •

DRUG SAFETY

N(

PATIENT SAFETY SPECIALIST

Novartis (Switzerland) •

01/2015 – 01/2020 •

PATIENT SAFETY

UP

Universidade Paulista •

01/2006 – 01/2010 •

Pharmacy (Pharm.D. / B.Pharm.)