Profile:More than 20 years working within Pharmacovigilance and Quality Assurance have given me a broad and extensive scientific knowledge within clinical and postmarketing safety and associated topics as safety database implementation and validation, outsourcing strategy and cross functional internal and external cooperation. As a manager I have shown a solid track record of building high performance teams, by allocating and prioritizing resources, focusing on competencies and development of potential by motivating and recognizing of team-success.I enjoy to build up and optimizing processes with focus on quality, results and empowerment. I contribute to a trusting, respectful, energetic and inquisitive environment. As a PV/GDP and GCP auditor I have performed more than 16 audits of relevant stakeholders and partners, contributing to quality development and compliance with legislations and procedures.Education: Postgraduate Diploma in Pharmacovigilance, Management development, Registered Nurse Contact: Annemettephilip@gmail.comSpecialities:LeadershipChange ManagementPharma Company IntegrationOutsourcing strategy and processesPharmacovigilance trainingSafety in Clinical trialsCRA and Investigator training in clinical safetyReconciliationSafety Reports Handling of ICSRsMedical assessment and evaluationSignal detectionSetting up Pharmacovigilance system in LOCsSafety Database implementation and upgrades (ARISg, agXchange and Argus safety)Computer system validationDatabase searches and analysisLiterature reviewPV partner agreementsQuality assurance, Audits and InspectionsRegulations and guidelinesPlanning and perform PV courses