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PV Operations Officer - Belgium  

Company managed [?] Still accepting applications

Posted on : 08 May 2017

Project Description

 PV Operations Officer  
Your responsibilities includes but not limited to:  
  • Establish and maintain productive alliance relationships with all key internal and external stakeholders in the review and implementation of Pharmacovigilance Agreements/Safety Data Exchange Agreements. 
  • Develop and maintain appropriate Pharmacovigilance Agreements/Safety Data Exchange Agreements for the company BCH organization with close collaboration with affiliates, business partners, vendors, Global Drug Safety, Global Regulatory Affairs and Global Quality Assurance. 
  • Participate in due diligence matters. 
  • Facilitate/Lead agreement negotiation meetings. 
  • Build safety agreement templates that are current with PV regulations and oversee their regular review and revision. 
  • Contribute to department initiatives (SOP review, process improvements). 
  • Develop KPIs and metrics for PhV partner and vendor agreements. 
  • Assist with the monitoring of PhV partner compliance to SDEA. 
  • Assist with process, tools and tracking mechanism for company BCH departmental deviations relevant to the SDEA 
  • Collaborate with management to achieve the objectives of the Department. 
  • Perform ad hoc duties & projects as assigned.  
  


LIAISON WITH AFFILIATES 
  • This role is instrumental in linking local PV activities to the central corporate PV 
  • You are responsible for effective communications processes and strong governance of local PV processes and their implementation/compliance at a regional/local level 
  • Coordinate the development and maintenance of the company pharmacovigilance network 
  • Support the EEA QPPV oversight, awareness and issues resolutions. 
  • Organize a quarterly affiliate safety meetings (TC) 
  • Support local PV initiated projects with Local PV contacts 
  • Coordinate PhV questionnaire with affiliates in relation to medicinal products and local PhV activities ensuring appropriate questions developed for the relevant PhV purpose. 



Your profile: 
  • Life science degree (pharmacy, medicine, …) or equivalent through experience. 
  • You have at least 3 years of significant and successful experience in international Pharmacovigilance with knowledge in Safety Data Exchange Agreements with Affiliates, vendors and business partners and liaison with Affiliates 
  • Highly analytical, process minded and detail oriented. 
  • Be able to work in a matrix environment whilst remaining organized at all times. 
  • You demonstrate initiative and capacity to work under pressure. 
  • You have a hands on-mentality and a proactive attitude. 
  • Your are fluent in English and have excellent communication skills. 
  • Knowledge of other European languages is an asset. 
  • You are a true team player and demonstrate leadership within cross-functional team environment.