Debbie Scott

About Debbie Scott

I am registered nurse with many years of critical care experience who stumbled pharmacovigilance when deciding to return for graduate studies for my master\'s degree in health care administration. I have over 15 years of PV experience in case processing including post market SAE reporting, litigation case reporting, literature, and clinical trial reporting in various therapeutic indications. As a team leader/manager I have training, audit,collaborating with QPPV to create and maintain PSMF, vendor oversight, and helping develop new PV professionals.

Experience

1. Lead Pv Operations

   Biogen

   Mar 2025 — Present

   Responsible safety operational content and processes for clinical trials such as protocols, CRFs, safety management plans, SAE forms, pregnancy forms; tools and processes for safety database requirements and configurations to enable safety-related activities during studies; training requirements and materials for clinical trial safety report collection• Review and archive PV related records in various documentation management systems • Support clinical trial safety report collection and collaborate with other functions (e.g, Clinical Operations, Data Management, Regulatory, Biostatistics, and others) to ensure consistency with regulations and study objectives• Oversee vendor performance and execute and monitor compliance through various monitoring reports and other oversight activities and ensures the implementation of effective Corrective and Preventative Action plans• Act as subject matter expert in audits / inspections, including leading Readiness for PV vendors• Identify gaps and areas of improvement within the PV system and lead strategic initiatives to address them• Develop, maintain and implement PV related procedural documents • Contribute to business alliance management• Establish business continuity plan for PV operation

Education

• Indiana University Indianapolis

  BSN, Nursing

  1983 — 1987

• University of Phoenix

  MSN/MBA HCA, Business/ Nursing in Health care adminstration

  2006 — 2009

Skills

• Good Clinical Practice (Gcp)
• Clinical Research
• Management
• Medicine
• Icu
• CRO
• Oncology
• Policy
• Diabetes
• Gcp
• Ctms
• Wound Care
• Hospitals
• Meddra
• Clinical
• Argus Safety
• Healthcare
• Quality Assurance
• Pharmacovigilance
• Cardiology
• Education
• Critical Care
• Treatment
• Clinical Trials
• Arisg
• Patient Education
• Nursing
• Supervisory Skills
• Pharmaceutical Industry
• Fda
• Drug Safety