Ana Cooper

About Ana Cooper

Pharmacovigilance and clinical development leader with over 15 years of experience across the pharmaceutical and clinical research landscape in both Brazil and the United States. I bring a proven record of leading safety operations, regulatory compliance, and cross-functional collaboration throughout the clinical trial and product lifecycle. I hold a Master of Business Administration and a bachelor’s degree in pharmacology, enabling me to bridge scientific rigor with strategic and operational leadership.I provide oversight and direction for pharmacovigilance activities including safety database strategy and governance, development and implementation of Safety Management Plans, and global regulatory safety reporting in alignment with FDA, EMA, MHRA, PMDA, ICH, and GVP requirements. I have extensive experience guiding medical review and safety signal evaluation, ensuring accurate benefit-risk assessment and inspection-ready documentation.My leadership experience includes establishing scalable safety processes, mentoring and developing high-performing teams, and partnering with Clinical Operations, Regulatory Affairs, Quality, and external vendors to ensure end-to-end compliance and operational excellence. I am highly skilled in adverse event oversight, MedDRA coding governance, safety data reconciliation, and the management of serious and non-serious adverse events for both investigational and marketed products.I am recognized for a quality-driven mindset, strong governance approach, and the ability to translate complex safety data into clear, actionable insights for senior leadership and health authorities. My work is grounded in continuous improvement, risk management, and a commitment to patient safety across global development programs.Core Expertise:Pharmacovigilance Leadership • Safety Governance • Global Regulatory Compliance • FDA • EMA • MHRA • PMDA • ICH • GVP • Clinical Trials • Safety Management Plans • Signal Management • Benefit-Risk Assessment • Safety Databases • MedDRA • Adverse Event Reporting • Vendor Oversight • Cross-Functional Leadership • Quality Systems • Inspection Readiness • Continuous Improvement

Experience

1. Pharmacovigilance Consultant

   Perspective Pharmacovigilance, Inc

   Aug 2021 — Present

Education

• Escola Superior Aberta Brasileira

  Master of Business Administration (MBA), MBA - Leadership and People Management

  2010 — 2011

• Universidade Estadual Paulista Júlio de Mesquita Filho

  Bachelor of Pharmacy (BPharm) and Biochemistry, Pharmacology and Biochemistry

  2004 — 2009

Skills

• Pharmacovigilance
• Gmp
• Patient Safety
• Clinical Research
• Regulatory Affairs
• Oncology
• CRO
• Pharmaceutical Industry
• Sop
• Gcp
• Clinical Trials
• Pharmaceutics
• Ich-Gcp
• Regulatory Submissions
• Pharmacology
• Ctms
• Clinical Operations