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.

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

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

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.

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.