Louise Hesselbjerg Rasmussen
Medical Safety Director, Veterinary QPPV, Human Deputy QPPV at Pharmacosmos- Claim this Profile
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Bio
Experience
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Pharmacosmos
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Denmark
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Pharmaceutical Manufacturing
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100 - 200 Employee
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Medical Safety Director, Veterinary QPPV, Human Deputy QPPV
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Nov 2023 - Present
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Medical Safety Director, Veterinary QPPV
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Aug 2023 - Nov 2023
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Medical Safety Director, Vet deputy QPPV
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Nov 2020 - Aug 2023
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PVA management specialist, Veterinary Deputy QPPV
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Jun 2020 - Nov 2020
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Lægemiddelstyrelsen (Danish Medicines Agency)
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Denmark
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Government Administration
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400 - 500 Employee
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Pharmacovigilance Officer
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Apr 2017 - Jun 2020
Copenhagen Area, Denmark -PSUR assessment. - Signal detection. - Signal management. - EudraVigilance: Search and assessment of ICSRs. - Development of processes in compliance with GVP IX. - DHPCs. - Author at "interaktionsdatabasen.dk". - Implementation of LEAN. -IT: EudraVigilance, EPITT, PSUR repository, MedDRA.
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Roskilde University
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Denmark
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Research Services
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700 & Above Employee
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PhD
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Dec 2011 - Nov 2016
Slagelse Hospital Experience: Project management with responsibility for planning, execution, controlling, and closing. Fundraising. National and International (USA and China) project collaborations. Independent and structured work approach to meeting deadlines. Ability to prioritise tasks. Approve and analyse data submitted by the project groups. Knowledge support to the project groups. Responsible for project quality assurance and documentation. Read and apply current legislation.… Show more Experience: Project management with responsibility for planning, execution, controlling, and closing. Fundraising. National and International (USA and China) project collaborations. Independent and structured work approach to meeting deadlines. Ability to prioritise tasks. Approve and analyse data submitted by the project groups. Knowledge support to the project groups. Responsible for project quality assurance and documentation. Read and apply current legislation. Scientific writing. Writing protocols for microbial trials. Experience of working in an ISO 15189 classified laboratory. Teaching of BSc and MSc students at Roskilde University – project supervisor and practical laboratory techniques. Supervision of laboratory technicians. Communicate results and knowledge to stakeholders: from laymen to peer-reviewed papers. Next generation sequencing. bioinformatics. Comparative genomics. Virulence determination. Phylogenetic analyses. DNA purification. Trouble shooting. Thesis title: A pathogenicity study on Mitis group streptococci: Molecular and genomic characterization of Infective Endocarditis provoking strains Publications: First author: In silico assessment of virulence factors in strains of Streptococcus oralis and Streptococcus mitis isolated from patients with Infective Endocarditis. J Med Microbiol. 2017 Sep 6 Whole Genome Sequencing as a Tool for phylogenetic analysis of Clinical Strains of Mitis Group Streptococci. Eur J Clin Microbiol Infec Dis. Eur J Clin Microbiol Infect Dis. 2016 Oct;35(10) Draft Genome Announcement of Type Strain Streptococcus gordonii ATCC 10558T. Genome Announc. 2016 Feb 18;4(1) Second author: Correct Species Identification of Streptococcus Using Multi Locus Sequence Analysis for Disproving Relapse of Two Episodes of Infective Endocarditis. The Open Infectious Diseases Journal, 2015, 9, 35-38. Show less
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Research Assistant
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Apr 2011 - Jun 2011
The Faculty of Life Science, University of Copenhagen A short employment focusing on publishing of the results obtained during the master thesis. Experiences: Scientific writing Writing protocols for microbial trials. Independently plan and conduct microbial biocide susceptibility testing and growth experiments. Analysis of data and communication of results. Analytical and structured work approach. Methods:. -Temperature growth experiments -Biocide susceptibility testing -MLST Publication:… Show more A short employment focusing on publishing of the results obtained during the master thesis. Experiences: Scientific writing Writing protocols for microbial trials. Independently plan and conduct microbial biocide susceptibility testing and growth experiments. Analysis of data and communication of results. Analytical and structured work approach. Methods:. -Temperature growth experiments -Biocide susceptibility testing -MLST Publication: Rasmussen LH, Kjeldgaard J, Christensen JP & H Ingmer (2013) Multilocus sequence typing and biocide tolerance of Arcobacter butzleri from Danish broiler carcasses. BMC Research Notes 6:322. Show less
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Education
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University Copenhagen, Faculty of Life Sciences
DVM, Veterinarian -
Technical University of Denmark
Organisational theory, project management, LEAN and business understanding. -
Høng Gymnasium & HF
Mathemathical -
Atrium
Pharmacoepidemiology -
Atrium
Introduction to Pharmacovigilance -
European Medicines Agency
EudraVigilance Training for NCAs