I am an experienced Global Pharmaceutical GCP and Pharmacovigilance Compliance project leader with broad expertise in health-care and pharmaceutical law, bioethics, science policy, regulatory life cycle product management, risk mitigation strategies and operational excellence.
I possess strong leadership skills with a sustained focus on human subjects protections, patients rights, compliance with the law and a need for continued scientific innovation.
My broad experience in Pharmacovigilance, Clinical Development, Clinical Quality, bioethics and personal health care delivery has challenged me to remain current, compliant, compassionate and diligent. As such, I strive to successfully implement quality process improvements linked to evolving regulatory requirements and global legislative changes which continuously impact scientific innovation, good research practices and the continued development of viable/sustainable heath-care options for all.
Core Qualifications include but are not limited to:
Pharmaceutical Law & Science Policy
Compassionate Use Expanded Access
Data Standards and Re-Use of Clinical Data
Clinical Data Sharing
Human Biological Samples
Protocol Design and Patient Centricity
Privacy and Confidentiality
Big Data 4 Better Outcomes
Lean Six Sigma Green Belt Certified
Strategic Risk and CAPA Management
Quality Optimization and Continuous Improvement
Scientific Innovation and Patient Advocacy
Project and Change Management