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Drug Safety Assistant - Belgium  

Keyrus Biopharma (company)


Posted on : 11 April 2017

Project Description

Job Description
We are looking for a Drug Safety Assistant for one of our clients.

  • Support safety alliance management activities (eg SDEA drafting, review, negotiation, termination, issue escalation) for low risk partners in accordance with the company's standards and in collaboration with relevant global and affiliate stakeholders.
  • Support maintenance of audit CAPA tracker.
  • Maintain SDEA internal periodic review status and ensure appropriate follow-up with the company's Local Safety Officers.
  • Support maintenance of SDEA related data in the Centralized Safety Agreement Management Database.  

  • University or medical background
  • Pharmacovigilance understanding with at least 3 years of experience in Pharma industry
  • Safety Data Exchange Agreement (SDEA) exposure to understand the requirements (2 to 3 years)
  • Legal understanding; 
  • Excellent reading & writing skills in English 
  • Understanding and experience with licensing, distribution or promotion agreements; 
  • Excellent skills in Microsoft Office Tools.  

What We offer
  • You will receive a competitive based salary depending on your education and experience in an attractive package of extralegal benefits (company car, petrol card, meal vouchers, group insurance, hospitalization…).
  • Each employee will be welcomed with a varied integration program. 
  • We invest considerable time and resources in training our staff (technical and non-technical courses). 
  • You will join a dynamic and international environment with enthusiastic and professional colleagues.

Who We are
Our company is a European full-service Contract research organization (CRO) providing biopharmaceutical, nutritional, cosmetic, animal health and medical device industries with a broad range of clinical research services from early- to late-stage clinical development, including project management, clinical monitoring, scientific and medical support, site management, biostatistics, data management, product safety, quality assurance, regulatory affairs, and medical writing.