Nichoel Wenzel

Budget Operational Support team, Pharmacovigilance department:

• Provide support with budget and resource management activities
• Help achieve financial department goals such as to maximize revenue by reducing unsupported hours
• New award study set-up with PV and Regulatory Affairs Budget analysis
• Multi-tasking between 25+ PV study's
• Manage safety budgets effectively, allocating resources per capacity in a global setting from the beginning-to-end of trial
• Establish strong communication relationships with project leads for forecast and budget actuals
• Support project leads, managers, analysts, and other admins daily
• Serve as a liaison between study / regulatory leads and analysts ensuring clear communication with budget reviews
• Maintain up-date team tabs for Pharmacovigilance and Regulatory Affairs projects
• Review cost and hours (over burn/ under burn) remaining budgets allocations for the life of the project
• Project knowledge includes Full-Service Outsourcing (FSO), Functional Service Partnership (FSP), Regulatory Publishing (RPS), Time and Material, Clinical Team Management (CTM)
• Country experience with Canada and US Solutions

Case Management team, Pharmacovigilance department:

• PPD Safety Tracking System (STS) software
• Ensure projects are properly resourced, managed and executed per requirements daily
• Managed approximately 100 incoming correspondence per day per timeline expectations
• Identify and redact subject identifiers per local requirements
• Emphasis on serious and non-serious adverse events
• Strong relationships with Safety Specialist, Data Safety Monitoring Board (DSMB) and Adjudication teams

Incoming Information Center (IIC), Pharmacovigilance department:

• Knowledge with multiple Shared Mailboxes
• Ensured all documents were streamed daily according to timelines
• Processing incoming information from sites via email and fax daily
• Execute documents through Safety Tracking System (STS) software for Medical Monitors and Safety Specialist
• Managed global safety hotline directing calls from trial sites for Medical Monitors and Safety Specialists
• Established strong communication with project team leaders, upper management and colleagues
• Assisted management in onboarding internal safety hotline in house to be managed by Safety Specialist instead of another vendor

• Excellent customer service
• Resolved customer complaints and issues to drive satisfaction and loyalty
• Managed high volume of customer requests, ensuring timely and effective service delivery
• Established and maintained service schedules daily
• Oversaw scheduling and dispatching of technicians, maximizing efficiency and minimizing delays in service daily
• Offered mentoring and training guidance
• Coordinated with vendors and suppliers to maintaining optimal inventory and parts required for services rendered
• Serving as the primary point of contact for customers, addressing inquiries, providing updates, and ensuring overall satisfaction with services rendered