Drug Safety and Surveillance Coordinator - Bilingual

    North York, Toronto, ON, Canada

    Kelly Services has an opening for a Bilingual Drug Safety & Surveillance Coordinator. This is a six-month contract assignment with possibility of extension based in North York Ontario. Candidates MUST be fluent in both English and French to qualify.

     

    The Bilingual Drug Safety & Surveillance Coordinator will report to the manager of Drug Safety and Surveillance. Superior attention to detail should be used to assist the department in maintaining compliance to applicable local and global SOPs as well as to Health Canada guidelines. Some of the responsibilities may include providing general administrative support for the department, as well as assistance and support with duties and responsibilities to ensure compliance with safety reporting and regulations, and responsibility for filing and maintenance of DSS department documents and AE case files. 

     

    Major Responsibilities: 

    • Manage departmental adverse event report intake 
    • Initiate case file documentation 
    • Record case file in Access local tracking system 
    • Perform case entry in SCEPTRE worldwide safety database 
    • Send safety reports to regional safety centers, affiliates and licensing partners, as applicable 
    • Prepare and submit cases to Health Canada 
    • Manage list of reportable cases to Health Canada 
    • Track cases due to Health Canada, Global Medical Organization (GMO) and affiliates to ensure compliance as per SOP, PV agreements and regulations 
    • Liaise with internal or external business partners as required for complete case documentation 
    • Provide ad-hoc support for safety data related requests 
    • Generate follow-up letters based on Safety review as required 
    • Provide monthly DSS reports 
    • Support departmental requests with GMO for safety database related items 
    • Maintain departmental documentation management according to corporate policies 
    • Provide departmental administrative support as required 
    • Liaise with Linguistics department and co-ordinate documents for translation 
    • Performs other related duties as required.  Job Knowledge Requirements: 

    Qualifications:

    • BA or BSc (Course work in science or health discipline preferred) 
    • Experience as a Drug Safety Coordinator or related duties as an asset 
    • Proficient skill level in Adobe Acrobat, Microsoft Word and mandatory advanced skills Microsoft Excel 
    • Bilingual (English and French) required 
    • Prioritization and organization of workflow activities in a team environment 
    • General working knowledge of document management systems 
    • Excellent communication and writing skills 
    • Superior level of attention to detail 
    • Ability to work in a team environment 
    • Excellent problem-solving abilities 
    • Ability to work in a team environment is critical 
    • Ability to work within tight deadlines 
    • Basic knowledge of medical terminology 

     

    Working Conditions 

    • No travel requirements 
    • Occasional lifting of file boxes

     

    If you have experience in drug safety, are proficient in Excel and are fluent in English AND French, please apply now!


    Category: Biotechnology & Pharmaceutical

    Reference ID: CA768JGR000040

    Date Posted: 22/11/2019

    Shortcut: http://jobs.en.kellyservices.ca/1xtuXY

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