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Safety Specialist - United Kingdom  

Company managed [?] Still accepting applications

Posted on : 26 February 2017

Project Description


THE ORGANISATION  
  • Our company is a global biopharmaceutical company focused on the discovery and development of innovative medicines and solutions to transform the lives of people living with severe diseases of the immune system or of the central nervous system. 
  • With 8 600 people in approximately 40 countries, the company generated revenue of € 3.3 billion in 2014.
  • Our company  aspires to be the patient-centric biopharmaceutical leader transforming the lives of people living with severe diseases. 
  • Our company  is growing to become the next generation bio pharma leader and need exceptional individuals to achieve this goal. 
  • We are looking for enthusiastic and talented professionals who thrive on challenge and change, and who want to make a difference and deliver results.  
  • At our company  human talent is the greatest asset of our organization – we continue to strengthen our talent pool, our organization and, our ability to deliver.  
  • We are building the next generation bio pharma leader and need exceptional individuals to achieve this goal.
  • We are looking for enthusiastic and talented professionals who thrive on challenge and change, and who want to make a difference and deliver results. 



THE POSITION  
The successful candidate will work in the BII  Safety team to actively contribute to ensure that pharmacovigilance systems are in place within the Territory in order to safeguard public health and maintain compliance with applicable regulatory requirements.    
  • Maintain knowledge of the applicable pharmacovigilance regulatory requirements; 
  • Contribute to establish and maintain the quality management system related to the pharmacovigilance system at the affiliate level, including deviation and CAPA management. 
  • Maintain local pharmacovigilance SOPs/AI to describe local processes and requirements  and perform  regular gap analysis as needed in order to ensure alignment with global SOPs; 
  • Interface with key affiliate stakeholders and departments in the local  office to ensure that pharmacovigilance requirements are implemented (eg PV interface with Market Research, Patient Support Programs, GxP vendor management) 
  • Provision of pharmacovigilance training to company  personnel and contracted staff including partners, as appropriate 
  • Collection, processing and reporting of ICSRs and Aggregate Reporting according to local regulations and company  procedures 
  • Organize reconciliation of adverse events and safety related information with affiliate stakeholders and vendors as required 
  • Contribute to establish, maintain and have oversight of all Safety Agreements which apply in BII; 
  • Participate to the International Safety network meetings, discussions and activities as delegated by line management.  
  


PROFILE
   
  • At least a few years in pharmacovigilance and Pharma industry/CRO with experience with affiliate operations. 
  • Good oral and written communication skills in English 
  • Scientific background.   
  • Ability to plan, organize, prioritize, and execute multiple tasks within assigned objectives in order to aim for 100 % compliance 
  • Have good interpersonal skills, Team worker 
  • High level of integrity and honesty, both internally and externally; 
  • Self-starter.  
  

 
    
Job Segment:  Pharmacovigilance, CAPA, Law, Public Health, Quality Manager, Healthcare, Management, Legal, Quality