Associate Director, Global Patient Safety, Canada (18 Month Contract)
Associate Director, Global Patient Safety, Canada
18 Month Contract
Hybrid Work- on average 3 days/week from office
Minimum 1 day from our Mississauga office and 2 days from our Mississauga or Downtown (temporary) office
At AstraZeneca, we pride ourselves on crafting a collaborative culture that champions knowledge-sharing, ambitious thinking and innovation – ultimately providing employees with the opportunity to work across teams, functions and even the globe. As we grow our vibrant hub in Mississauga, we are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible. We welcome applications from candidates across Canada who are open to starting a new adventure.
The role of Associate Director, Global Patient Safety, Canada is responsible for the local Canadian pharmacovigilance system. They are the local safety point of contact for internal and external stakeholders and responsible for ensuring that local and global pharmacovigilance requirements are adhered to across portfolios.
Main Accountabilities:
Manage the local Patient Safety (PS) team, including day to day operations, performance management and coaching of team members
Maintain an in-depth knowledge of Canadian regulations, updating regional lead and local teams with any new changes in legislation/guidance for discussion and escalation to relevant stakeholders in global PS
Oversee and manage all patient safety related processes, activities, issues, and gaps at the country level, taking charge of necessary actions to address them effectively
Provide analysis and trending of data or collaborate with stakeholders to identify trends through project management
Lead and ensure the development and implementation of the PS process and strategy at the local level to achieve overall business objectives
Provide input into significant important decisions and projects, typically on a multi-country or local level
Act as the PS Contact Point with the Health Canada to manage Individual Case Safety Report (ICSR) related queries, AZ product-related safety concerns, or activities relating to the Risk Management Plan (RMP)
Act as GVP Lead, implementing all elements of Quality management systems related to patient safety (Change Management, Continuous Improvement plan, Issues, Root Cause Analysis, CAPAs, Risks, Self-assessment, Management review meetings, Vendor quality review, PS Agreements, Training & etc.)
Manage external vendors that deliver PS services, maintaining effective business relationships
Establish strong relationships and effective cross-function collaboration with regulatory, marketing, medical, and other internal and external stakeholders’ functions to deliver patient safety requirements for business and regulatory needs
Maintain oversight of all safety-related processes, issues, and brand activities in Canada, including product risk management plans and associated activities
Ensure that all local information relating to pharmacovigilance activities is reflected correctly in the Pharmacovigilance System Master File (PSMF)
Maintain current knowledge of the marketed status of products in the local country and reference documents (such as Product Information/Datasheet) in addition to maintaining up-to-date knowledge on global PS procedures/guidance
Provide PS expertise and guidance within the local Marketing Company (e.g., Marketing, Sales, Regulatory Affairs, Medical Affairs) related to the safety data for a given product, PS processes and risk and issue management
In line with the Global Process, support the response to related safety issues and questions arising from customers (healthcare practitioners, patients), and communicate response to the consumer, as required
Coordinate, host, and actively participate in internal and external audits and inspections, including preparation and audit follow-up activities
Essential for the role:
Qualified degree in Pharmacy/Medical/ Science
5 years or more in a pharmacovigilance leadership role and 3 years or more of people management experience
Extensive knowledge of pharmacovigilance and Health Canada regulations
Experience with audits and inspections and must have prior experience with hosting/leading and/or managing functions or rooms during a health authority inspection
Prior experience being interviewed by Health Canada inspector
Thorough knowledge of Good Pharmacovigilance Practice
Cross function collaboration
Leadership skills & act as a role model for the local PS team
Project management & proven record on above-market PS projects
Effective thinking & problem solving
Vendor Management
Patient Safety systems management
Excellent attention to detail
Excellent written and verbal communication skills
Desirable for the role:
Healthcare professional or PharmD degree
Bilingualism in French and English
Problem solving, influencing, and conflict resolution skills
Understanding of multiple aspects of Medical Affairs, Regulatory, Clinical Research, and Commercial Operations
Medical knowledge in AZ/Alexion Therapeutic Areas
Argus safety database experience
Medical marketing experience
Change management skills
Great People want to Work with us! Find out why:
Office Working Requirements
When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working gives us the platform we need to connect, work at pace and challenge perceptions. That’s why we work, on average, a minimum of three days per week from the office. But that doesn’t mean we’re not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world.
Are you interested in working at AZ, apply today!
AstraZeneca is an equal opportunity employer that is committed to diversity and inclusion and providing a workplace that is free from discrimination. AstraZeneca is committed to accommodating persons with disabilities. Such accommodation is available on request in respect of all aspects of the recruitment, assessment and selection process and may be requested by emailing AZCHumanResources@astrazeneca.com.
#LI-Hybrid
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 authorisation and employment eligibility verification requirements.
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