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Drug Safety Officer Case Management - Belgium  

Company managed [?] Still accepting applications
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Posted on : 08 May 2017

Project Description

Job Description 
Responsibilities:    
  • Data handling of all adverse events and special situations according to appropriate SOP and WI’s 
  • Data entry and causality assessment adverse events into the PcV manager 
  • Ensure timely reporting to competent authorities and safety partners 
  • Coordination of Pregnancy Follow Ups Continuous updating of all relevant documents and Overviews (e.g. lists for literature search,...) 
  • ADR reconciliation with safety partners (co- distributors, manufacturers, …) 
  • ADR reconciliation with complaints and affiliates 
  • Reconciliation of medical enquiries with complaints and affiliates 
  • Provide input to Sr. PV Operations Officer on ICSR handling/ data entry/reporting for creation of training material 
  • On the job training, evaluation and coordination of PV colleagues on case handling and using the global safety database 
  • Coordinating quarterly checklist 
  • Handling of information and results of global literature search 
  • Coordinating Local literature search and literature searches for other purposes (e.g. PSUR, ACO) 
  • Ordering of articles and coordinating the translation of articles 
  • Coordinating ICSR collection from MLM service 
  • Managing the global pharmacovigilance mailbox 
  • Querying and eextracting data out of the global safety database 
  • Extraction of KPI for data entry data from the PcV manager  
  

  

Requirements:
  • A life science degree is required 
  • A minimum of 1-2 years of experience in PV/Drug safety in case management/processing 
  • MedDRA experience 
  • Strong oral and written communication skills 
  • Ability to manage workload and meet strict deadlines 
  • Be able to work in a matrix environment whilst remaining organized at all times 
  • Fluent in English, other languages are an asset 
  • Proficient in MS Office applications (Excel, Word, Outlook). 
  • Knowledge of medical terminology