Drug Safety Associate
Tfs Trial Form Support AB / Biologjobb / Uppsala
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hela Sverige TFS is expanding and we are looking for a Drug Safety Associate that wants to join our great team in Stockholm! For this particular position, you will be working as an outsourced consultant at one of our client's facilities, a pharmaceutical company in Uppsala.
TFS is a Global CRO headquartered in Sweden. We genuinely believe that ?GLOBAL IN MIND AND LOCAL AT HEART is the core of our success; we operate in a global environment while retaining an in-depth knowledge of regulatory and clinical trial requirements in every country where we operate. We value a close working relation with our customers, and with our employees.
We have local offices in Stockholm, Gothenburg and Lund where your colleagues and reporting line manager collaborate with you and support and coach you in your work. If you are interested in joining a dynamic and growth oriented organization ? Welcome to TFS.
The Drug Safety Associate is part of the Project Delivery organization and will work with assistance on handling of drug safety/vigilance issues according to company policies, SOPs and regulatory requirements.
• Support to handling of SAE in clinical trials and spontaneous reports from the market, to ensure collection, assessment and entering into the safety database in accordance with the TFS/clients' SOPs and existing demands of the authorities
• May review cases and write draft narratives of AE and SAE reports, as required
• May code adverse events, medical history and concomitant medication
• Support to SAE-reconciliation
• DCF handling
• Correspondence and archiving
• Assist in registration and other matters of EudraVigilance
• Participate in relevant project groups/meetings
• Assist in internal support to other relevant departments
• May provide updates of templates for safety handling in specific studies/projects according to relevant SOPs
• Actively contribute to the organization and development of routines to enhance the work at TFS
• Being well-informed and updated on laws, directives and guidelines concerning handling and reporting of SAEs in clinical trials and serious as well as non-serious events from the market (pharmacovigilance) and other safety issues
Requirements/Qualifications:
• BSc Degree preferably in pharmacy, biomedicine, nursing or equal.
• 1-2 years? experience from a similar role is a great advantage.
• Understand the basic medical terminology and science associated with the assigned drugs and therapeutic areas
• Have the basic understanding of the Good Clinical Practice regulations, ICH guidelines, Pharmacovigilance legislation and internal SOPs
• Demonstrate proficiency using typical word processing; spreadsheets desirable
• Good verbal and written communicate skills both in English and Swedish.
As a person you exhibit attention to detail, have strong interpersonal skills and the ability to work effectively and efficiently in a fast-paced environment with changing priorities. You have an ability to work independently and take decision on your own. We are looking for team oriented candidates with great organizational and communication skills
For more information about this position please contact:
Maja Lindeblad, Recruitment Specialist, at +46 721 561302 or
maja.lindeblad@tfscro.comWe are looking forward to receiving your application with included CV and a personal letter. We are working with continuous selection so please submit your application as soon as possible at
www.tfscro.comVaraktighet, arbetstid
Visstidsanställning 6 månader eller längre
Heltid
Publiceringsdatum2016-10-19ErsättningFast månads- vecko- eller timlön
Så ansöker duAnsök via TFS hemsida;
Klicka på denna länk för att göra din ansökanFöretagTFS TRIAL FORM SUPPORT AB
AdressTFS TRIAL FORM SUPPORT AB
Box 165
22100 LUND
KontorsadressScheelevägen 2
LUND
Övriga kontaktuppgifterTelefonnummer: 046-280 18 00
Jobbnummer 3115097
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