Drug Safety Specialist (Contract) - Canada
Want to know company name or location? Company managed [?]
- 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.
- 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.