I am an accomplished compliance professional with medical training, diverse life science industry experience, and advanced healthcare law and compliance training.
During over twenty years in the industry working in Drug Safety, Pharmacovigilance, and Compliance, I was exposed to a variety of small and large companies, consulting organizations, and international law firms. Pursuing an interest in legal issues impacting the life sciences, I completed my Master of Science degree in Jurisprudence (focusing on Pharmaceutical and Medical Device Law & Compliance) from Seton Hall University School of Law.
With my diverse experience and expertise, I am well-prepared to assess and assist in mitigating cross-functional business and regulatory challenges in compliance or pharmacovigilance organizations.
Specific Areas of Expertise Compliance: Auditing; Corrective and Preventative Actions (CAPAs); Enforcement Actions; Gap Analysis; Health Authority Inspections; Regulatory Intelligence; Identifying and Mitigating Compliance Risk in Commercial/Medical Affairs Activities; Monitoring; Workplace Investigations
Pharmacovigilance (PV): Safety Operations; Global PV Inspections; Risk Evaluation and Mitigation Strategies (REMS); Medical Communications; Commercial Field Staff Training; Establishing and Overseeing PV Outsourcing Activities; Patient Support Programs; Social Media; Digital Health
Quality Management: Contract Review and Negotiation; Metrics; Policies; Procedures; Process Improvement; Training
Project Management: Global Cross Functional Compliance Initiatives; Health Authority Submissions