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Julius Clinical (company)


Posted on : 29 May 2017

Project Description

 Want to contribute to safe innovative drugs?
  •  We are focusing on the development of new and innovative medicine that have a major impact on people's lives. 
  • We perform clinical trials in therapeutic areas such as cardiology, diabetes, CNS and infectious deseases. 
  • At this moment we have an interesting opportunity for a Pharmaceutical Physician (BIG registered). 
  • Our new Pharmaceutical Physician will manage and provide all medical and safety aspects of our clinical trials, will also be involved in protocol reviewing and provide scientific input. 
  • You will work in a close-knit team of responsible colleagues. 
  • It is a diverse job in an organisation with short lines, with excellent opportunities to put your ideas for improvement into practice.
  • The Pharmaceutical Physician reports to the Director Medical Affairs of our Medical and Safety team.

Tasks and responsibilities
Clinical study level:
  • Provides medical and safety input into proposals, bid defenses and protocols; 
  • Coordinates, supports and provides medical and safety input and activities to internal and external clients during all phases of the project, including periodic status reporting of the designated project(s); 
  • Ensures, in collaboration with Safety Officers, safety reports and documents are in place and handled according to set timelines and quality of designated projects;  
  • Ensures all necessary procedures, systems, tracking tools and documents are in place;  
  • Represents the department during in- and external meetings;  
  • Collaborates effectively in (project) teams;   

Individual patient care:
  •   Adjudicates, advances and safeguards the health of individual subjects by medical review medical monitoring (including but not limited to: adverse events, medication, diagnostics) and signal management (early signals will be detected to ensure safety of subjects); 
  •   Advises and informs investigators and sponsor on medical issues; 
  •   Advises and informs ethical committees and regulatory authorities on medical issues; 
  •   Advises investigators and sponsor on eligibiliy (compliance to all inclusion and exclusion criteria); 
  •   Participates in steering committee and data review meetings as safety expert; 
  •   Responsible for the process of safety reporting of the individual subjects participating in clinical trials within applicable regulations and according to EU Directive, guidelines; 
  •   Advises on continuation of trial drug- if applicable. 

Desired skills & experience
  • Medical Doctor with Dutch BIG registration; 
  • A minimum of 2 years experience in the pharmaceutical and/or CRO industry or equivalent clinical research experience; 
  • Preferable familiar with Pharmacovigilance / safety databases such as PV 24/7; 
  • Excellent (English) oral and written communication skills; 
  • Analytical, decisive, flexible, result driven, proactive; 
  • Ability to balance medical competence with industry standards to achieve business goals.