The focus for this role is to lead aspects of the safety reporting requirements, training and processing for AstraZeneca Canada.

Responsibilities:

• Manage the case handling process and act as the day-to-day contact to the global Patient Safety team
• Ensure local regulatory timelines are met through Jasper and electronic reporting system requirements and associated metadata updates and report issues of non-compliance
• Provide local input to licensing agreements and all third-party contracts within the organization where safety reporting or medical information processes may be relevant
• Develop, deliver and/or coordinate training and guidance for employees and contractors to adhere to AstraZeneca standards and Code of Ethics requirements related to safety reporting
• Coordinate internal and external audits and inspections
• Support compliance with global and local regulatory reporting timelines through training and system/process guidance
• Main global contact with global Quality Assurance and local Quality Assurance for defining training requirements for Patient Safety
• Write and/or train and implement local and/or global Standard Operating Procedures
• Collaborate closely with Medical Information and Quality Assurance to define reporting processes
• Main contact for global Safety surveillance teams regarding case quality requirements
• Support the Director and the Manager, Patient Safety with the implementation and compliance of company and regulatory requirements by performing compliance and quality reviews and follow-up
• Review and provide input into all organized data collection programmes (e.g., market research, websites, etc.) and ensure safety reporting is incorporated
• Review and advise, as required, on Clinical Study protocols and any Medical Evidence studies including Externally Sponsored Research
• Provide input to global teams, representing Patient Safety at the Marketing Company (i.e., inspection readiness, reference teams, etc) and be the interface for inspections and audits

Minimum Qualifications:

• Post-secondary education is required - college diploma and/or university degree in a health-related area of study preferred
• Demonstrated leadership skills in the areas of critical thinking, acting decisively, driving performance, working collaboratively, passion for the customer and developing people and the organization
• 5 years’ Patient Safety (Drug Safety/Surveillance)/Regulatory Affairs experience & knowledge of Medical Information processes and medical terminology
• Thorough understanding of Good Clinical Practice, International Conference on Harmonization guidelines and Canadian regulatory requirements
• Superb interpersonal skills and attention to detail is required
• Strong organizational skills

About AstraZeneca Canada:

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 quickly to inspire change. We are courageous, taking smart risks and learning from both success and failure. We are curious, creative, and open to new insights and ways of working. Above all, we are passionate about science and driven to always put patients first. Join us at our great place to work; an environment that energizes and empowers each of us to achieve our goal to develop and deliver medicines.

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.