Louise Larsen Email & Phone Number

Søborg, Denmark

Patient Safety.Responsible for surveillance of product in development phase.Collaboration with safety CRO and clinical CRO.Input to and evaluation of clinical CRO selection.Preparing and driving internal safety committee meetings. Involved in interpretation and presentation of phase 1 data. Input to phase 1 and 2 trial outline, protocol and informed consent form in collaboration with clinical CRO. Presenting at investigator meeting. Driving creation/update of internal risk overview, minimum mandatory safety text (MMST), Development Safety Update Report (DSUR).Timely input for Investigator’s Brochure (IB), Clinical Overview, Clinical Trial Applications (CTAs)/Investigational New Drug (IND) Applications.Co-organising social events.

Søborg, Denmark

Safety Surveillance, Global Safety.Surveillance of post-marketing sources and clinical trials, signal management, stakeholder management across functional areas. Responsible for product in post-marketing phase, non-interventional studies, handling lifecycle tasks, followed by successful handover.Responsible for surveillance of clinical pharmacology and 3a clinical trials for product in development phase. Preparations for market authorization application, submission, questions/answers phase, FDA advisory committee. In addition, safety committee chair.Delivering timely input to new drug applications, variations, response documents, audits, inspections, interventional/non-interventional study protocols and reports, informed consent forms, aggregated reports.Process expert for safety committees, content responsible for SOP, involved in local implementation of new regulation, and other activities across departments.Representing Novo Nordisk in collaborations with other companies: EFPIA CT PV group focussed on implementation of the EU Clinical Trials Regulation.Organizing “We Bike to Work” sign-up and virtual social breaks during the work-from-home-situation due to the COVID-19 pandemic.

Bagsværd, Denmark

Safety Surveillance, Global Safety.Surveillance of post-marketing sources and clinical trials, signal management, safety committee chair (since April 2018).Responsible for product in post-marketing phase, stakeholder management across functional areas.Timely input as safety surveillance adviser to: IB, RMP, PSUR, DSUR, periodic SUSAR, clinical trial outline/protocol/report incl. experience with paediatric population, submission/response documents, label, safety committee, external data monitoring committee, audits, inspection.Experience with FAERS and EVDAS.Organizing DHL relay race sign-up.

Nordics

Technical Sales Specialist (TSS) for Protein Biology covering the Nordics.Handling sales of products used in the laboratory, such as kits and small machines.Adviser and problem solver for customers in Denmark, Sweden, Norway and Finland.

New Jersey

Project: Investigation and manipulation of the trafficking of leptin receptor in hypothalamic neurons from lean and obese rats.Supervisor: Professor MD Barry Levin.Department of Neurology and Neurosciences, New Jersey Medical School.Techniques: Dissociation and culture of hypothalamic neurons from rats followed by immunohistochemistry and calcium influx measurement in neurons to determine glucose and leptin sensitivity.

Copenhagen Area, Denmark

PhD project: Identifying the microRNA expression profile in the developing rat pancreas and elucidating mRNA targets of microRNAs regulated around time of birth with a putative role in the islet of Langerhans and the insulin producing beta cells (thesis: Expression of MicroRNAs in Perinatal Rat Pancreas).Supervisor: Professor DrSc Jens Høiriis Nielsen.Beta Cell Biology group at the Cellular and Metabolic Research Section.Techniques: Dissociation and culture of pancreatic islet of Langerhans from rats followed by micro-arrays, northern blotting, western blotting, qRT-PCR, insulin detection by ELISA and microRNA in situ hybridizationFebruary-May 2010: Visiting researcher at PhD Susan Bonner-Weir's lab at Joslin Diabetes Center, Boston, MA.Funding:European Foundation for the Study of Diabetes (EFSD)The Danish PhD School of Molecular MetabolismCopenhagen Graduate School of Health Sciences

Copenhagen Area, Denmark

Project: MicroRNAs and pancreas.Supervisor: Professor DrSc Jens Høiriis Nielsen.Beta Cell Biology group at the Cellular and Metabolic Research Section, Department of Biomedical Sciences, Faculty of Health Sciences, University of Copenhagen.

Copenhagen Area, Denmark

Master's thesis: Analysis of the Cytoplasmic Polyadenylation Elements in the 3' Untranslated region of p53 mRNA.Supervisor: Professor DrSc Bodil Norrild.The DNA Tumorvirus Group, Department of Cellular and Molecular Medicine, Faculty of Health Sciences, University of Copenhagen.Techniques: Transfection of cell lines followed by northern blotting, western blotting, qRT-PCR, pull-down assay and immunohistochemistry.

Postgraduate Diploma, Pharmacovigilance, With Distinction

Part-time distance learning postgraduate programme in Pharmacovigilance. Pharmacoepidemiology (Sep-2019) Labelling and Risk Management.

Phd, Health Sciences

PhD thesis carried out at the Cellular and Metabolic Research Section, Department of Biomedical Sciences, Faculty of Health and Medical.

Cand.Scient./Msc, Biology

Master's thesis carried out at the DNA Tumorvirus Group, Department of Cellular and Molecular Medicine, Faculty of Health Sciences.

Bach.Scient./Bsc, Biology

Education record