Profile #7093

My extensive knowledge in and passion for Pharmacovigilance & patient safety, comes from 14 years of experience and include all aspects of safety surveillance in both clinical development and post-marketing Pharmacovigilance.
pharmacovigilance patient safety clinical development & documentation neurology regulatory strategy & submission data analysis safety databases adverse events  
Updated 27. august 2020
My education
1996 - 2005

Cand.scient. i Biokemi

Københavns Universitet

Thesis title: ”Clock gene expression in PC12 cells”.
Major: Molecular Neurobiology.
Educational area: Naturvidenskab
Period: august 1996 - april 2005
My work experience
2016 - now

Principal Safety Scientist

H. Lundbeck A/S

All aspects of Pharmacovigilance; medical review and assessment of (S)AEs from clinical studies and post-marketing sources, writing clinical study reports, DSURs/PSURs, RMPs, performing signal detection, data-cleaning and safety review. Training new colleagues and optimize procedures. Primary field of action: Patient safety, Alzheimer’s disease, drug dependence and neurology.
Work area: Medicinal & Sundhed
Period: april 2016 - now
2017 - 2020

Health, Safety & Environment representative

H. Lundbeck A/S

  • Participate in Safety inspections
  • Participate and follow up on work place assessments
  • Introduce new employees to the Health, Safety & Environment system, including emergency procedures
  • Participate in goal-setting for the local Health, Safety & Environment group, together with management representative
  • Entering accidents in the accident database and following up
    • • Supporting colleagues in various aspects, wherever needed
    Work area: Medicinal & Sundhed
    Period: juni 2017 - juni 2020
    2007 - 2016

    Safety Officer

    Statens Serum Institut

    My responsibilities and knowhow in my job as Safety Officer in Regulatory & Medical Affairs at Statens Serum Institute include all aspects of safety surveillance in both clinical trials, clinical development and post marketing Pharmacovigilance. Listed here is a selection of some of my qualifications:
  • Solely responsible for all safety surveillance in clinical trials, where Statens Serum Institute are Sponsor
  • Monitoring data and signal-finding from clinical trials
  • Handle, evaluate and report SUSARs, composing and submitting listings and DSURs to relevant partners, Competent Authorities and Ethics Committees
  • Writing regulatory clinical documents used for e.g. registration approvals like clinical development plans, clinical summaries, clinical overviews, Paediatric investigation plans/waivers, briefing documents and background material for scientific advises.
  • Co-author and review of clinical documents e.g. protocols, IBs, clinical trials reports, due to my unit Medical Affairs work close together with the departments developing new products.
  • Investigate national requirements and legislations when a clinical trial is conducted and compose SOPs for the clinical trials, as instructions for my colleagues.
    • As part of the post-marketing Pharmacovigilance responsibilities, I have taken part of all areas in safety surveillance for the products produced/distributed by Statens Serum Institute
    Work area: Medicinal & Sundhed
    Period: maj 2007 - marts 2016
    2006 - 2007

    Safety Assistant

    Actavis

    Reading scientific articles and authority reports, evaluation and follow-up as well as data entry into databases. Sending expedited reports to relevant authorities. Proof-reading of electronic reports entered by co-workers. Participating in project groups to maintain and improve Pharmacovigilance processes.
    Work area: Medicinal & Sundhed
    Period: februar 2006 - april 2007
    2005 - 2005

    Scientific Researcher (M.Sc.)

    Bispebjerg Hospital

    After establishing that the mammalian, differentiated cell line PC12 is showing circadian rhythm after serum-shock stimulation, has it been decided that the cell culture can be used as a model system for studies of different transmitters effect on the daily rhythm at specific times during the day/night. Experiments of this type have been carried out for the last year. I have shown that different neurotransmitters have influence on the expression of the clock genes period 1 and period 2.
    Work area: Forskning & Udvikling
    Period: maj 2005 - december 2005
    My skills and abilities
    Skills
    authoring dsurs and periodic susar reports authority requests crfs data cleaning ibs icfs labeling updates monitoring and analysing adverse events protocols safety database handling signal management smps surveillance of adverse drug reactions testing and implementing new systems/updates tmfs training colleagues trend- and signal management writing aggregated reports writing instructions and sops*
    Skills at working proficiency
    dansk engelsk
    My preferences
    Job type
    Fuldtidsjob
    Work areas
    Forskning & Udvikling Medicinal & Sundhed Naturvidenskab
    Location
    Storkøbenhavn
    Salary
    55.000 DKK / month
    Read more / links
    https://www.linkedin.com/in/ca...
    Contact me!