Ouderkerk aan de Amstel, North Holland, Netherlands
Project Manager | Project Coordinator | Pharmacovigilance | Computer System Validation | PVWorks | Adverse Event & PQC Reporting | SharePoint Administration | Social Media Engagement | Microsoft Office | Open to exploring opportunities to collaborate.
Project Management / Pharmacovigilance / Regulatory / Computer System Validation / Virtual Assistant / Social Media & Reputation Management
Lead project teams to successfully integrate legacy PV systems and processes - establishing new ways of working within the global PV organization Collaborate with stakeholders to develop and define project charters, project plans, project milestones, work packages, communication plans, risk analysis, and to align on project status updates Engage and lead global project teams to implement integrated data warehouse to support PV activities Lead and support multiple project sub-teams in the implementation of systems and processes to support new European Veterinary Legislation 2019/6 across global affiliate locations Track progress on, develop content for and facilitate delivery of PV project portfolio progress and updates to Global PV Leadership Team Lead data migration and integration of AE reports from legacy systems to new PV database
Coordinate and manage projects related to the PV Works computer system used to manage Adverse Events and Product Quality Complaint reports. Plan and lead Computer System Validation projects for validated PV systems Manage PV system access requests and requisite training Design, build, and act as administrator for PV related SharePoint sites Manage vendor training, functional relationship and define and deploy processes related to managing electronic communications including social media
Successfully manage US Pharmacovigilance database change management through defining scope, creating schedules, assigning work packages, and collaborating with intra/inter-departmental stakeholders in an environment regulated by the FDA, EPA, USDA, and NASC Responsible for authoring computer system validation (CSV) documentation in accordance with Global and Regional SOPs Act as site administrator for multiple SharePoint sites; developing technological efficiencies for the Pharmacovigilance (PV) team and inter-departmental colleagues Subject matter expert on PV and ERP system integration, process implementation, managing Social Media and electronic communications
Co-Managed CSV project activities - coordinated with stakeholders in various work-groups to define and achieve project goals on schedule and within quality constraints Identified, developed, authored, and facilitated change management and process improvements Co-authored CSV documentation and ensured compliance with Global and Regional SOPs Created and developed Sharepoint sites, acted as site collection administration of Sharepoint sites Facilitated the delivery, documentation, and analysis of over 2,000 annual electronic (including social media) communications
Analyzed and recorded EDI sales from over ten different contracted distributors into SAP ERP system Coordinated, reconciled, and documented reported sales and inventory levels for a consigned FDA regulated product responsible for ~70MM of annual sales Traveled to contracted vendor locations to develop, enhance and support positive working relationships and to audit inventory levels of consigned product Performed set-up and maintenance of Customer Master Data in SAP ERP and AS400; co-developed a sales reporting reconciliation process with distributors
Planned, developed and executed new-hire training, ongoing technical training, and personal development courses for staff members. Analyzed training needs to develop new training programs and content; provided recommendations to modify or improve existing programs to senior leadership. Developed and implemented E-Commerce POS sales system for high-fashion retailer resulting in a 20% increase in sales. Provided mentoring, coaching and development for a team of 15-25 Customer Service Agents.