Vesna Cucuz

Global Patient Safety Database Systems Manager @Ipsen

Oxford, GB
MOBILE NUMBERS
+91 *********19

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WORK HISTORY

Nov 2016 — Present

Global Patient Safety Database Systems Manager @Ipsen

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Abingdon, GB

Defining the GPS safety systems strategy and roadmap.• Systems expert for questions and training, for audits and inspections, and for driving best practice.• Working with the SVP Head of GPS and EU QPPV to define the strategic direction for Ipsen safety systems, ensuring that current needs are met, and that all available information about future needs is considered as early as is feasible.• Maintaining the efficient operation of the global drug safety database to ensure compliance with all PV regulatory obligations, business continuity and accessibility of all safety data to meet business requirements.• Ensuring that the day-to-day operating of the GPS database and associated systems is in full compliance with all applicable PV legislation.• Ensuring the appropriate tools, processes and resource are in place to deliver efficient data collection and outputs.• Ensuring that the appropriate tools, processes and resource are in place to derive all expedited, periodic and ad hoc data outputs from the database, to ensure full compliance with legislative reporting requirements and to provide appropriate responses to all regulatory authority and appropriate internal company requests for data, analysis and information.• Ensuring the appropriate tools, processes and resource are in place to deliver efficient data collection and outputs. • Ensuring that the appropriate tools, processes and resource are in place to derive all expedited, periodic and ad hoc data outputs from the database, to ensure full compliance with legislative reporting requirements and to provide appropriate responses to all regulatory authority and appropriate internal company requests for data, analysis and information.

SKILLS

MeddraGcpIch-GcpCROClinical TrialsGvpMedical DevicesClinical ResearchPharmaceutical IndustryFdaDrug SafetyRegulatory AffairsArisgRegulatory SubmissionsPharmacovigilancePatient SafetyGood Clinical Practice (Gcp)21 Cfr Part 11Clinical OperationsEudravigilanceRegulatory RequirementsClinical Monitoring

ABOUT VESNA CUCUZ

Global Patient Safety Database Systems Manager at Ipsen

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