Associate Director, Regulatory Affairs & Safety

• Jan 2022 - Present

Regulatory Affairs And Safety Manager

• Oct 2020 - Dec 2021

Phase I, II & III clinical trial application coordination and submission (initial protocol submissions and amendments) for medicinal products and medical devices.Clinical Trial Master File set-up and management.Phase I, II & III pharmacovigilance set-up and maintenance.EudraVigilance EVCTM and XEVMPD registration.Safety case review and reporting.Case narrative writing for CSR.DSUR writing and submission.MedDRA and WHO Coding.Medarbejderrep. i Arbejdsmiljøorganisation Show less

Regulatory Affairs & Safety Manager

• May 2016 - Sep 2020

Phase I, II & III clinical trial application coordination and submission (initial protocol submissions and amendments) for medicinal products and medical devices. Clinical Trial Master File set-up and management. Phase I, II & III pharmacovigilance set-up and maintenance. EudraVigilance EVCTM and XEVMPD registration.Safety case review and reporting.Case narrative writing for CSR.DSUR writing and submission.

Regulatory Affairs Manager & Safety Advisor

• May 2014 - Apr 2016

Phase II & III clinical trial application coordination and submission (initial protocol submissions and amendments) for medical products and medical devices. Clinical Trial Master File management. Phase I, II & III pharmacovigilance set-up and maintenance. EudraVigilance EVCTM and XEVMPD registration.Safety case review and reporting.Case narrative writing for CSR.

Regulatory & Safety Manager

• Jan 2013 - Apr 2014

Phase II & III clinical trial application coordination (initial protocol submissions and amendments) for medical products. Clinical Trial Master File management. Phase I, II & III pharmacovigilance set-up and maintenance. EudraVigilance EVCTM and XEVMPD registration.Safety case review and reporting.

Pharmacovigilance Manager

• Jan 2011 - Dec 2012

Registration of serious adverse events in accordance with current rules and regulations (national and international). Write and update internal PV plans and SOPs etc.Serious adverse event reconciliation between system, sponsor and clinical investigation sites.CRF safety setup and UAT.

Pharmacovigilance Associate

• Jun 2009 - Dec 2010

Registration of serious adverse events from clinical studies (phase I-III) in accordance with current rules and regulations (national and international). Drug logistics. Serious adverse event reconciliation between system, sponsor and clinical investigation sites. Registration of serious adverse events from clinical studies (phase I-III) in accordance with current rules and regulations (national and international). Drug logistics. Serious adverse event reconciliation between system, sponsor and clinical investigation sites.

Research assistent

• Jun 2008 - Dec 2008

Research within schizophrenia and Alzheimer's disease. Research within schizophrenia and Alzheimer's disease.

Specialestuderende

• Feb 2007 - May 2008

In vivo research regarding Alzheimer's disease model in rats. Stereotaxic surgery, EEG measurements, fear conditioning, auditory evoked potential. Enzyme assay - scintillation. In vivo research regarding Alzheimer's disease model in rats. Stereotaxic surgery, EEG measurements, fear conditioning, auditory evoked potential. Enzyme assay - scintillation.

Scolarstipendiat

• Jul 2005 - Mar 2006

Research assistent, performed pharmacological studies, both in vivo and in vitro. Research assistent, performed pharmacological studies, both in vivo and in vitro.