About AstraZeneca

Here you’ll have the opportunity to make a significant difference to patients’ lives. With science at its heart, this is where breakthroughs born in the lab become transformative medicines – for the world’s most complex diseases. Answer unmet medical needs by pioneering the next wave of science, focusing on outcomes and shaping the patient ecosystem.

With our ground-breaking pipeline, the outlook is forward-thinking. Be proud to give to a place that has achieved so much, yet is still moving forward. There’s no better time to join our global, growing enterprise as we lead the way for healthcare and society

Position Type: 12 month Contract

Location: Mississauga

AstraZeneca in Canada

Headquartered in Mississauga, Ontario, we’ve been recognized as one of Greater Toronto Area’s Top Employers for 7 straight years. Our work environment cultivates knowledge-sharing, decision-making, and entrepreneurial thinking. Our employees have the opportunity to work across teams, functions, and even the globe. With a commitment to sustainability, we’re working towards making our head office and internal and external meetings green.

Business area

Taking a forward-looking approach we look at the world through a different lens. We go above and beyond to find solutions that impact patients – harnessing science with technology and connecting the entire healthcare ecosystem. It’s our patients that come first, every decision we make and action we take is centered around how we can better serve them. It’s why we are shaping patient care for the future, working along the whole experience to give hope to billions of lives across the world.

What you’ll do

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 during Business Continuity Plan (BCP) situations as directed by the respective managers
• Provide support during audits and inspections, help with audit readiness
• Back-up for Process Manager, Patient Safety Associates for the following activities, as required
• Develop, deliver or organize training and guidance for AZ Canada organization 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
• Conduct other PS/pharmacovigilance related tasks as assigned by manager

Your qualifications include:

• 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 / pharmacovigilance processes.
• Knowledge of medical terminology.
• Thorough understanding of SOPs, GVP, ICH guidelines and Regulatory Requirements.
• Effective social 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.

Why AstraZeneca?

This is the place to make an important impact – on patients’ lives and your personal growth. It’s both rewarding and inspiring, and it’s what keeps us motivated every day.

Great People want to Work with us! Find out why:

• GTAA Top Employer Award for 7 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/
• Browse AstraZeneca's YouTube channel to find out more about us:https://www.youtube.com/user/astrazeneca

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.