About AstraZeneca:

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 worldwide and by leading breakthrough science that promises to transform the treatment of disease.

Our purpose is ambitious and so is our approach. Becoming a more agile and innovative company means building a dynamic, inspiring culture where we celebrate forward thinking and act with a sense of urgency. We are daring, 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. Are you ready to move forward in your career? Join us and be part of an extraordinary place to work; an environment that energizes and empowers each of us to achieve our goal.

Position Title: Process Manager, Patient Safety & Medical Information

Position Type: Full-Time, Permanent

Location: Mississauga, Ontario

Career Level: D

The focus for this role is to oversee Canadian marketing company safety reporting requirements, training and processing.

Responsibilities:

General Accountabilities:

• Conduct activities and interactions consistent with Company values and in compliance with the Code of Ethics and supporting Policies and Standards relevant to this role.
• Complete all required training on the AstraZeneca Code of Ethics and supporting Policies and Standards on time.
• Report potential issues of non-compliance.

Process Manager Patient Safety & Medical Information Accountabilities:

• Manage the case handling process and act as the day-to-day contact with global Patient Safety over specific cases and linkages with global Patient Safety teams
• Ensure local regulatory timelines are met through Jasper and electronic reporting system requirements and associated metadata updates
• 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 organize training and guidance for AstraZeneca Canada 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 and Medical Information
• Write and/or train and implement local and/or global Standard Operating Procedures
• Liaise with Medical Information and Quality Assurance to define reporting processes
• Main contact for global Safety surveillance teams regarding case quality requirements
• Support the Director, Patient Safety & Medical Information and the Manager, Medical Information 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 organised data collection programmes (e.g., market research, websites, etc.) and ensure safety reporting is incorporated, as applicable
• Review and provide input, as required, to Clinical Study protocols and any Medical Evidence studies including Externally Sponsored Research
• Provide input to global Patient Safety teams, representing Patient Safety at the Marketing Company (i.e., inspection readiness, reference teams, etc)
• Act as the global Patient Safety interface for inspections and audits
• You will build partnerships functional authorities, internally and externally and provide oversight to ensure successful study delivery
• You will maintain and facilitate interactions with internal functions including Data Management, Procurement, Regulatory, Patient Safety and Quality Assurance, and external functions including the CROs and other outside service providers to ensure an efficient study delivery.
• You will lead and/or participate in the preparation of delegated study documents (e.g. Informed Consent Form, master Clinical Study Agreement etc) and external service provider related documents (e.g. specifications)
• You will support the Global Study Leader (GSL) in project management as per agreed delegation
• You ensure the supply of study materials and Investigational product by liaising with Clinical Supply Chain or external service providers
• You help support the GSL with budget management, such as external service provider invoice reconciliation
• You make sure studies are inspection-ready at all times according to ICH-GCP, AZ SOP and relevant policies/guidelines
• You will ensure that all study documents in scope of GSAM’s responsibilities are completed and verified for quality in the Trial Master File
• You will assist with the planning and conduct of internal and external meetings (e.g. Investigator/Monitors meeting)
• You will monitor study conduct and progress, dedicatedly identifying and resolving risks and issues which may impact delivery of the study to the necessary quality, timeline or budget objectives with the Global Study Manager
• You will contribute to ad hoc team productivity and efficiency by providing direction and facilitating positive team dynamics
• You will have the opportunity to provide input into non-drug project work including training activities, and development of procedures as needed

Minimum Qualifications:

• University degree (or equivalent), preferably in medical or biological sciences or discipline associated with clinical research
• 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 strategic 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
• Knowledge of medical terminology
• Thorough understanding of Standard Operating Procedures, Good Clinical Practice, International Conference on Harmonization guidelines and local regulatory requirements
• Superb interpersonal skills, attention to detail and organizational skills  is required
• Significant experience from within the pharmaceutical industry or similar organization or academic experience, preferably of at least 3 years
• Shown project management, organizational and analytical skills
• Knowledge of clinical development / drug development process in various phases of development and therapy areas (respiratory TA knowledge would be an asset) and relevant knowledge of international guidelines ICG-GCP

• Computer proficiency

Next steps – Apply today

To be considered for this exciting opportunity, please complete the full application on our website at your earliest convenience – it is the only way that our Recruiter and Hiring Manager will know that you feel well qualified for this position. Do you know someone who would be a phenomenal fit? Please share this posting with them.

AstraZeneca is an equal opportunity employer. AstraZeneca will consider all applicants for employment without discrimination on grounds of disability, sex or sexual orientation, pregnancy or maternity leave status, race or national or ethnic origin, age, religion or belief, gender identity or re-assignment, marital or civil partnership status, protected veteran status (if applicable) or any other characteristic protected by law.

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

• GTAA Top Employer Award for 5 years: https://content.eluta.ca/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/
• Total Rewards for employees: https://www.astrazeneca.ca/en/working-at-az-canada/Total-Rewards.html

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.