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Drug Safety Specialist (Contract) - Canada  

Celgene (company)


Posted on : 21 March 2017

Project Description

  • Our company  is a global biopharmaceutical company leading the way in medical innovation to help patients live longer, better lives. 
  • Our purpose as a company is to discover and develop therapies that will change the course of human health. 
  •  We value our passion for patients, quest for innovation, spirit of independence and love of challenge. 
  • With a presence in more than 70 countries - and growing - we look for talented people to grow our business, advance our science and contribute to our unique culture.  
  • There is a requirement for a Contract Drug Safety Specialist, mandated to manage safety data reported to our company in accordance with corporate and regulatory requirements.   

Responsibilities include, but are not limited to:   
  •  Management of Adverse Event (AE) case data through the receipt ad triage of local AE reports received from Health Care Professionals or consumers.  
  • Reporting of such to Global Safety via the global safety database. 
  •  Initiation and conduct of follow-up activities related to local AE reports including direct telephone follow-up as required. 
  •  Assessment of local and global clinical trial and post marketed serious AE reports for submission to Health Canada in accordance with federal requirements.  
  • Provision of support to the Submissions Associate for all submission activities. 
  •  Support senior team members in training activities related to Drug Safety & AE reporting both internally and externally. 
  •  Assist senior team members in the management and maintenance of good customer relationships both internally with the company Affiliate office and externally with key customers. 
  •  Assist in responding to safety inquiries received from Health Care Professionals or Health Canada. 
  •  Maintenance of high compliance standards with respect to reporting timeliness and quality of local AE data. 
  • Ensuring all standard operating documents are followed and that the department is inspection/audit ready at all times. 
  •  Champion company  Values.

Skills/Knowledge Required:
  • A health professional background, preferably a degree in Pharmacy or Nursing 
  •  Two years clinical experience preferred 
  •  Good clinical knowledge of therapeutic area, patient populations and drug class 
  •  Excellent computer skills with full proficiency of MS-Office Applications 
  •  French language skills preferable 
  •  Knowledge of Health Canada requirements with respect to ADR Reporting and Pharmacovigilance activities 
  •  Self-starter with superior time management skills, and ability to work independently or in team 
  •  Very strong attention to detail 

This is a 12 month contract role.