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Drug Safety Officer Lund Sweden,  

TFS (company)


Posted on : 02 March 2019

Project Description

description

“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 requirements in every country where we operate. at tfs, you will be offered the possibility to develop in a global organization with a company culture distinguished by passion, Innovation and talent.”


general description:

the Drug Safety officer is part of the project delivery organization and will work on handling of Drug Safety/vigilance issues according to company policies, sops and regulatory requirements.


essential job functions

  • 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
  • review and approval of processed cases and ae/sae reconciliation
  • coding of adverse event, medical history and concomitant medication according to MedDRA and who-drug dictionary
  • qc and approval of coding of adverse event, medical history and concomitant medication
  • review and write the safety section in clinical study protocols
  • review of Clinical Trial reports/ibs from a safety perspective
  • write the safety parts in the psur/pbrer, dsurs, ind, nda and other safety documents
  • literature search
  • electronic reporting to eudravigilance
  • contribute to plans/instructions and sops for post approval surveillance
  • updating of templates for safety handling in specific studies/projects according to relevant sops
  • may act as a project lead for safety-only projects
  • participate in relevant meetings. forward information to relevant members of the department or study team members
  • provide internal support to other relevant departments
  • involved in improvement projects with other relevant departments
  • actively contribute to the organization and development of routines to enhance the work at tfs
  • Validation of computer Applications specific for the department with respect to Drug Safety requirements
  • 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.
  • Education and supervision of new Drug Safety personnel
  • participate in Marketing activiti

requirements


  • bachelor’s degree, preferably in life science or Nursing; or equivalent
  • 5 years of relevant experience
  • able to work in a fast-paced environment with changing priorities
  • ability to work independently as well as in a team matrix organization with little or no supervision
  • demonstrate proficiency using typical word processing; spreadsheets desirable; and presentation Software a plus

benefits

what can we offer you?

a great place to work where you will get the chance to push your Career to the next level, global environment with global opportunities. you will also get the opportunity to be part of a team with highly intelligent, passionate experts from all over the world. tfs is a place for inspiration where we focus on the patients, saving lives and aiming to increase their quality of life by supporting our clients.”

Locations

Lund, Skåne County, Sweden

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