International collaboration, business development, vendor management, project management and coordination, team and line management, vendor qualification assessment, audits and CAPAs
Detailed skills & experience
International multidisciplinary drug development experience: I have worked together with colleagues from all phases of drug development and I have personal experience from the pre-clinical process development, authorization submission phase, pre-authorization preparation, launch activities and post-marketing phase activities.
Project management, multiple projects, time management, tasks, delegation and coaching: I have experience with managing and coordinating projects related to pharmacovigilance. I have worked as a project manager for several projects simultaneously and overseeing the management and coordination of dozens of other projects at the same time. (Not the way I would prefer to work but I can manage it.)
I have been responsible for overseeing the time tracking of my team and our vendors (monthly reports and invoice approval).
Due to the high workload demonstrated above I have been constantly developing new ways to assign tasks, delegate and to improve my coaching skills.
Planning, tracking, Agile working: I am working on waterfall for clients but for my own team management and my projects I prefer Agile and Lean working methods. I was managing a team that had employees located in four countries so we developed suitable distance working methods.
Compliance: I worked as a project coordinator for the local compliance officer. Our team was implementing the EFPIA disclosure code regarding transparency of transfer of value to healthcare professionals and publication of the information. I was the operational lead in the implementation project where I had to closely collaborate with our financial control team and ERP team for the SAP implementation of the related module.
Inspection and qualification assessment: I acted as the SME in our organization for vendor qualification assessment working together with the quality assurance team. As the head of the department I was the auditee and SME in several audits and inspections every month. I was responsible for determining the root causes for any possible findings and assigning the corrective and preventive actions to fix these issues.
My previous corporate position was Director of International Development at a leading pharmacovigilance service provider. I have previous working experience with pharmaceutical companies in product quality, compliance and R
I am available to work at any location.