At AstraZeneca, we are united by a common purpose – to push the boundaries of science to deliver life-changing medicines. This purpose underpins everything we do; our work helps to make hearts healthier, to help people breathe easier, and to help more people survive cancer. Every single day, we make a difference by delivering potentially life-changing medicines to millions of people and by leading breakthrough science that promises to transform the treatment of disease.

Our purpose is bold and so is our approach. Becoming a more agile and innovative company means creating a vibrant, dynamic culture where we celebrate entrepreneurial thinking and act with a sense of urgency. We are courageous, taking smart risks and learning from both success and failure. We are curious, creative, and open to new ideas and ways of working. Above all, we are passionate about science and driven to always put patients first. Join us and be part of a great place to work; an environment that energizes and empowers each of us to contribute to achieving our goal to develop and deliver life-changing medicines.

Position Type: Full Time, 12-month

Location: Mississauga

In this position, you will conduct the local case handling process for Patient Safety Canada for marketed products, and to ensure compliance with company and regulatory requirements, as well as key performance indicators.. 

Responsibilities:

• Perform all steps within case-handling process for all cases
• Identify and request appropriate follow-up information on cases in consultation with the PS Process Manager and other PS personnel or Medical Information as required to ensure all cases meet reporting standards
• Ensure PS Process Manager (or other PS personnel, as applicable) is made aware of any adverse event which may have medical, regulatory, legal or other consequences and thus, managed in accordance with procedures
• Maintain well-documented files for each case to provide an audit trail and satisfy requirements of any regulatory inspection, local and global AZ audits
• Maintain basic knowledge of disease and therapeutic area
• Perform ongoing SAE reconciliation and emergency unblinding during conduction of studies, as well as end-of-study unblinding of local studies, as applicable
• Emergency unblinding coverage after hours, as required
• Review of MHPD line-listing reports and entry into safety database
• Perform daily Global Medical information Platform (GMIP) reconciliation for adverse events
• Support other roles in PS/MI during Business Continuity Plan (BCP) situations as directed by the respective managers
• Provide support during audits and inspections, contribute to audit readiness
• Back-up for Process Manager, Patient Safety & Medical Information for the following activities, as required:
  • Develop, deliver or organize training and guidance for AZ Canada organisation and contractors
  • Write and/or train local and global procedures and processes.
  • Perform QA/QC reviews related to case handling.
  • Review and provide input to marketing programs related to safety reporting.
  • Provide safety training to internal/external staff.

Qualifications:

• Post Secondary Education is required. College Diploma and/or University Degree in a health related area of study preferred.
• 2 - 3 years working knowledge of Adverse Event reporting processes.
• Knowledge of medical terminology.
• Thorough understanding of SOPs, GVP, ICH guidelines and Regulatory Requirements.
• Effective interpersonal skills and attention for detail is required.
• Ability to share knowledge through effective written and verbal communication.
• Ability to manage and participate in cross functional team projects.
• Ability to speak French is an asset.

Great People want to Work with us, find out why:

• GTAA Top Employer Award for 6 years: https://reviews.canadastop100.com/top-employer-astrazeneca-canada
• Best Workplace Culture Award at the 2018 Canadian HR Awards: https://www.linkedin.com/pulse/thriving-best-workplace-culture-gena-restivo/
• Learn more about our culture: https://www.linkedin.com/posts/genarestivo_greatpeople-greatplacetowork-topemployers2020-activity-6608742174811049985-N-8G

Are you interested in working at AZ? Apply today!

Date Posted

Closing Date

AstraZeneca embraces diversity and equality of opportunity.  We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills.  We believe that the more inclusive we are, the better our work will be.  We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics.  We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.