Safety assesment specialist
Dfind Science & Engineering AB / Apotekarjobb / Stockholm
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Consultant assignment as Drug Safety Specialist
On behalf of our client we are now looking for a consultant as Drug Safety Specialist
Job Purpose
To support management of drug safety and pharmacovigilance operational processes in ensuring compliance with global/local procedures, national and international regulations/ standards/guidelines for pharmacovigilance of marketed and investigational products.
The Role, examples of some of the major activities;
1. Manage collection, processing, documentation, reporting and follow-up of all serious adverse events reports for all products from clinical trials, and all adverse events from Patient Oriented Programs, post-marketing studies , registries, and all Spontaneous Reports.
2. Transcribe, translate and enter data of all Serious Adverse Events (SAE) from Clinical Trials, and all adverse events (from Patient Oriented Programs, post-marketing studies, registries and all Spontaneous Reports) from source documents onto safety systems accurately and consistently with emphasis on timeliness and quality.
3. Record and track receipts, submissions and distributions of SAEs, SRs, Investigator Notifications , SUSARs, Periodic Safety Report Updates (PSUR) and Development Safety Update Report in cooperation with other departments.
4. Manage reporting/submission/distribution of safety reports/updates/information) to Local Health Authorities (LHA) and/or clinical operations in cooperation with other departments.
5. Work with other local/global PVO associates to ensure accurate evaluation of safety data.
6. Interact and exchange relevant safety information with LHA, PVO associates, other functional groups and third party contractor, if applicable.
7. Survey and monitor national pharmacovigilance regulations and provide update to global PVO organization.
The assignment is planned to start as soon as possible and last until 6 months, with chance to be prolonged.
Employer: Dfind Science & Engineering
Placement: Stockholm
Recruitment rate: Full time
Last day to apply: 2015-04-30
For information: Linnéa Edvardsson 072-5168909,
linnea.edvardsson@dfind.se [ mailto:
linnea.edvardsson@dfind.se ]
Qualification
• Degree in medicine , pharmacy or life science
• IT Software skills
• Excellent written and verbal English , Good written and verbal Swedish and Knowledge of other languages desirable
Skills and Capabilities
• Knowledge of national and international regulations for pharmacovigilance
• Knowledge of pharmacological and medical terminology.
• Excellent communications, interpersonal and negotiation skills
• Quality and focus oriented
• Attention to details, highly organized and able to plan and control
Please write your CV and cover letter in English. We look forward to your application!
Organisation:
Dfind Science& Engineering, former Proffice Life Science is part of the Proffice Group, one of the Nordic region's largest specialists within staffing, recruitment and outplacement.
The Proffice Group consists of Proffice, Dfind and Antenn and it has over 10,000 employees in the Nordic area.
Dfind Science& Engineering is specialized in recruitment and consulting providing competences within Life Science, Science and Engineering and is a company where people make all the difference. At Dfind Science& Engineering specialists are recruiting specialists!
All our recruitment consultants , consultants and sourcing managers have a technical or scientific background, combined with extensive networks within relevant communities and expertise within recruitment and HR. We understand our customers specific requirements and know how to find the best candidates. Through our passionate commitment and high degree of attentiveness we help people and businesses to grow and be competitive in a changing world.
Varaktighet, arbetstid
Heltid Visstid
Publiceringsdatum2015-04-15ErsättningFast lön
Så ansöker duSista dag att ansöka är 2015-05-01
Ange följande referens när du ansöker: 200740565
Ansökan sker via företagets webbplats.
KontaktLinnéa Edvardsson
linnea.edvardsson@dfind.seFöretagDfind Science & Engineering AB
AdressDfind Science & Engineering AB
Regeringsgatan 65
10724 STOCKHOLM
KontorsadressRegeringsgatan 65, 10724 STOCKHOLM
Jobbnummer 2250036
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