Associate Director, Global Patient Safety, Canada

**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**

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**:

- GTAA Top Employer Award for 11 years
- Top 100 Employers Award
- Canada’s Most Admired Corporate Culture
- Learn more about working with us in Canada
- View our YouTube channel

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