Qualified Person Pharmacovigilance (qppv) To The Headoffice In M
Nordic Drugs / Apotekarjobb / Malmö
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hela Sverige Visa alla jobb hos Nordic Drugs i Malmö Nordic Drugs was first established in Sweden in 1995 and its head office is in Malmö.
The Nordic Drugs companies are dedicated Marketing and Sales structures in the Nordic Group with a strong presence in the Scandinavian countries, and in particular in the primary care and retail pharmacy markets.
Since 1995, Nordic Drugs has built a solid reputation in Pain Management and Antibiotics, as well as an interesting portfolio of branded generic and OTC products. Today, Nordic Drugs' main therapeutic areas are, Pain & Inflammation, Infection, Gastroenterology and Critical Care.
In addition to a sturdy traditional marketing presence in the primary care and retail pharmacy markets in Scandinavia, Nordic Drugs is also present in the secondary care market.
Today, Nordic Drugs is present throughout Scandinavia and is recognised by doctors and pharmacists for being a competent and very reliable partner who provides quality products at competitive prices. Nordic Drugs is currently one of the fastest growing pharmaceutical companies in Scandinavia.
Selected strategic alliances and licensing agreements aimed at significantly broadening the Nordic product portfolio in its core therapeutic areas are important elements in achieving Nordic's long-term development objectives in Scandinavia.
Please visit our website :
www.nordicdrugs.comJob description
Assignments:
Pharmacovigilance
Having knowledge of applicable EU Pharmacovigilance legislation and guidance, international standards for Pharmacovigilance.
Establishing and maintaining Nordic Drugs Pharmacovigilance system including written procedures.
Training of Nordic Drugs personnel in the area of Pharmacovigilance.
EU-QPPV for products for which Nordic Drugs is MAH.
Responsible for:
• having a overview of the safety profiles and any emerging safety concerns in relation to the medical products;
• acting as a single contact point for Competent Authorities (CAs) on a 24-hour basis
• having oversight of the Pharmacovigilance system in terms of structure and performance and ensure:
a) the establishment and maintenance of a system which ensures that information about all suspected adverse reactions which are reported to the personnel of Nordic Drugs is collected and collected in order to be accessible at least at one point within the EU;
b) the preparation and submission of reports to CAs, such as Individual Case Safety Reports (ICSRs) and Periodic Safety Update Reports (PSURs);
c) the conduct of continuous overall Pharmacovigilance evaluation during the post-authorisation period;
d) that any request from the CAs for the provision of additional information necessary for the evaluation of the benefit and risk afforded by a medicinal product is answered fully and promptly.
• establishing and maintaining Pharmacovigilance agreements with partners
• act as the contact points for Pharmacovigilance inspections
Local Safety Officer for products which Nordic Drugs is local representative (task performed as applicable according to the Pharmacovigilance Agreement with each MAH)
• act as the national contact point for CAs in Pharmacovigilance matters
• collection and initial processing of safety information
• contact with MAH for exchange of safety information
• submission of expedited reports to competent authorities
• keep track of and perform PSUR submission
• establishment and maintenance Pharmacovigilance agreements with MAH
Medical/pharmaceutical information
• assist product- and sales managers in answering questions from patients/doctors/pharmacies etc
Other
• participate in Nordic Drugs monthly meetings
Contact and your application
If you have any questions please contact Eew, Assessio, 070-896 89 02.
Send your application with CV via
www.assessio.se/rekrytering as soon as possible but not later than December 14.
Publiceringsdatum2010-12-01Arbetstider och omfattningTillsvidare
ErsättningEnligt överenskommelse
Så ansöker duSista dag att ansöka är 2010-12-14
Ansökan kan tyvärr inte göras via e-post.
Ansökan sker via företagets webbplats.
KontaktEwa Lanner, +46 40 12 02 01
FöretagNordic Drugs
AdressNordic Drugs
Årstaängsvägen 1C
10074 Stockholm
Jobbnummer 791341
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