Kimberly Behan

About Kimberly Behan

WHO I AM: An operations expert and Pharmacovigilance professional with more than 15 years of broad-based experience that extends across quality assurance, regulatory reporting, project management, integration following business acquisition, and process re-engineering.WHAT I DO: Elevate productivity, profitability, and compliance through skillful development and implementation of new business models, operational strategies, and change management plans.VALUE I BRING: My leadership extends beyond the tactical functions I have managed. I am a dynamic business partner who promotes a shared operational vision across the organization. By managing relationships at all levels and ensuring open lines of communication, I motivate global, cross-functional teams to successfully navigate substantial organizational change. SKILLS⇨ Organizational Effectiveness⇨ Process Redesign⇨ Change Management⇨ Project Management⇨ Business Transformation⇨ Global Team Leadership⇨ Problem Resolution⇨ Quality Assurance⇨ Cost Control⇨ Global Communication⇨ Regulatory Compliance⇨ Relationship Management⇨ Mergers & Acquisitions⇨ Training & Education

Experience

1. Global Safety (Gs) Executive Director Us Safety and Global Case Management

   Merck

   Mar 2010 — Present

   Oversees all aspects of daily operations for adverse experience case processing across Colombia, China, India, Poland, and The Netherlands. Serves as the main point of contact for adverse experience case reporting during global Health Authority inspections (FDA, EMA, MHRA) and Business Partner Audits. Provides direction and oversight for mission-critical, cross-functional projects such as integration following corporate mergers/acquisitions, cost control programs, and process re-engineering. Created an organizational structure to ensure regulatory compliance of global operations for adverse experience case processing including establishment of a Quality Management System. Maintained compliant case processing of adverse experiences for Merck and Schering Plough while directing integration activities such as process harmonization and launch of a single safety database. Implemented a new business model that used both outsourcing and insourcing to provide flexibility and business continuity that resulted in significant cost savings.

Education

• West Chester University of Pennsylvania

  Bachelor of Science, Nursing

Skills

• Global Leadership
• Clinical Development
• Change Management
• Pharmacovigilance
• Project Management
• Relationship Management
• Process Redesign
• Quality Assurance
• Mergers & Acquisitions
• Training & Education
• Organizational Effectiveness
• Regulatory Compliance
• Regulatory Affairs
• Clinical Trials
• Pharmaceutical Industry
• Sop
• Fda
• Medical Writing
• Global Communication
• Regulatory Submissions
• Oncology
• Global Team Leadership
• Cost Control
• Clinical Research
• Standard Operating Procedure (Sop)
• Gcp
• Problem Resolution
• Business Transformation