Junior Regulatory Officer
Proffice Life Science AB / Apotekarjobb / Stockholm
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hela Sverige Visa alla jobb hos Proffice Life Science AB i Stockholm,
Solna,
Sundbyberg,
Danderyd,
Huddinge eller i
hela Sverige On behalf of our client we are now looking for a Junior Regulatory Affairs Officer for a short term assignment in Stockholm. Preferred starting date is end of may/beginning of june and the position will end by august 31. Prolongation is possible but not guaranteed.
Accountabilities/Responsibilities:
• Basic regulatory tasks, e.g. archiving, preparing photocopies, sending documents to Health Authorities and so on.
• Handle complaints:
• Enter basic information into the enterprise quality management system, called Trackwise.
• Order/send pharmaceutical product samples
• Have access to the QC inbox, decide the level of urgency of QC complaint (based on the SOP) and send to the Registration/QC for investigation.
• Have access to the Pharmacovigilance inbox and decide the level of urgency of PV case (based on the SOP) and send to the Registration/PV for investigation
• Enter summary in Trackwise, QC and change controls
• Send QC response letters based on more senior function approval
• Archiving correspondence of regulatory officers, quality documents into the clients internal archives
• Update databases
• Update FASS with respect to updates to Patient Information Leaflet and SmPC.
• Make an inventory of the pharmaceutical storage.
Requirements:
• Newly graduated with an academic degree in Chemistry, Pharmacy or Biology or several years of experience as an assistant within Pharmaceutical companies.
• IT Software skills (Excell, Word).
• Excellent written and verbal English and Swedish.
Skills and Capabilities:
• Structured
• Flexible
• Performance driven
• Concern for standards
• Team Working skills
• Social skills
Please do not hesitate to send in your applications as soon as possible if you have the right profile.
Special emphasis will be placed on personal suitability.
We only accept your application at our homepage,
www.profficelifescience.se.Publiceringsdatum2011-04-27Arbetstider och omfattningVisstidsanställning 3 - 6 månader
Heltid
ErsättningFast lön + rörlig lön
Så ansöker duSista dag att ansöka är 2011-06-13
Ansökan kan tyvärr inte göras via e-post.
FöretagPROFFICE LIFE SCIENCE AB
AdressPROFFICE LIFE SCIENCE AB
BOX 70368
10724 STOCKHOLM
KontorsadressMÄSTER SAMUELSGATAN 60
STOCKHOLM
KontaktuppgifterTelefonnummer: 08-7871700
Jobbnummer 914976
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