Deb Fox Email & Phone Number

Conduct risk based internal audits to ensure corporate governance, risk management and internal controls are robust to meet company standards and regulations.

North Chicago, Illinois, Us

Conducted PV audits to ensure compliance with worldwide regulatory requirements for all safety and pharmacovigilance activities for AbbVie as well as pharmaceutical affiliates and partner companies that provided safety data for AbbVie products. Maintained effective communication with affiliates/partner companies and management of corrective and preventative action (CAPA) plans to ensure close out of actions. Conducted training for CAPA process. Reviewed regulatory documents to assess impact on PV QA processes. Consulted with business partners in regards to PV compliance issues, particularly with FDA requirements and expectations. Supported Due Diligence process.

Cambridge, Cambridgeshire, Gb

Career progression from Quality Control Scientist to Global position as Enablement LeadProvided insight on Pharmacovigilance standards and regulations. Reported and reacted to Global performance metrics to identify improvements and maintained compliance. Provided integrated strategic safety expertise to product development programs and marketed brands; some examples include implementation of Important Clinical Event and adverse event reporting with class action law suits. Also provided oversight, line management, performance management, leadership and direction to high performing team. Provided regulatory awareness and implemented inspection readiness activities to ensure compliance. Interacted with Regulators during inspections regarding compliance program for adverse event reporting.

-Reviewed protocols, informed consents, IRB approval-Negotiated protocol changes-Managed all financial responsibilities for Phase IV research-Coordinated shipping of clinical supplies to study sites-Tracked clinical supply needs, monitor patient recruitment and tracked study milestones-Developed clinical guidelines for reporting SAEs

Managed cardiac and pulmonary outpatient rehab center, line management, monitored patients enrolled in clinical trials.• Oversight of center’s operations and nursing care of cardiac and pulmonary outpatients• Designed and implemented outpatient pulmonary rehab program increasing revenue for center.• Acknowledged for being highest enrolling center in Tristate area for CARS study.

Philadelphia, Pa, Us

Provided nursing care for critical care patients• Rotated through Intensive Care unit, Coronary Care Unit and Neurological Intensive Care Unit• Interpret cardiac rhythms• Mentored nurses

Unit secretary while going to school to become a LPN• Provide organization for the unit: transcribing physician orders, scheduling patients for procedures and maintain patient charts• As an LPN provided patient care on a medical surgical care unit and administration of medications

Registered Nursing

Master’S Degree, Quality Assurance/Regulatory Affairs

Bachelor’S Degree, Registered Nursing/Registered Nurse

Associate’S Degree, Registered Nursing/Registered Nurse