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Drug Safety Specialist (Contract) Mississauga Canada,  


Posted on : 21 March 2017

Project Description

Req #: 17000511 Location: Mississauga, ON CA Job Category: Medical Work Location: Mississauga, Ontario 6755 Mississauga Road Suite 600 Mississauga L5N 7Y2 Organization: Celgene Inc. Schedule: Full-time Shift: Day Job Employee Status: Limited Term Job Type: Internship Job Level: Individual Contributor Travel: No DescriptionCelgene 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 Celgene Canada 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 Celgene 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 Celgene Values.QualificationsSkills/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.     *LI-TS1

Locations

Mississauga ON CA

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