Patient Safety Process Manager

1 week ago

Mississauga, Canada AstraZeneca Full time

This role will be based from our Mississauga head office where we have adopted a hybrid model of working in office an average of three days per week.

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.

Recognizing the importance of individualized flexibility, our ways of working allow employees to balance personal and work commitments while ensuring we continue to create a strong culture of collaboration and teamwork by engaging face-to-face in our offices 3 days a week. Our head office and BlueSky Hub in downtown Toronto are purposely designed with collaboration in mind, providing space where teams can come together to strategize, brainstorm and connect on key projects.

Our dedication to sustainability is also central to our culture and part of what makes AstraZeneca a great place to work. We know the health of people, the planet and our business are interconnected which is why we’re taking ambitious action to tackle some of the biggest challenges of our time, from climate change to access to healthcare and disease prevention.

**Our Position**

The focus for this role is to manage aspects of the safety/pharmacovigilance reporting requirements, ensuring compliance with AstraZeneca Canada regulatory requirements governing the conduct of pharmacovigilance.

**Responsibilities**:

- Oversee the AZ PV system, being in a position to assure the following components:

- 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 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
- Write and/or train and implement local and/or global Standard Operating Procedures
- Lead the development and co-creation of local Canadian Risk Management Plans through the drug lifecycle based on the approved core document
- Collaborate closely with Medical Information and Quality Assurance to define reporting processes
- 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/pharmacovigilance 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 Patient Safety teams, representing Patient Safety at the Marketing Company (i.e., inspection readiness, reference teams, etc)

**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/Pharmacovigilance)/Regulatory Affairs experience & knowledge of medical terminology
- Thorough understanding of Good Clinical Practice, Good Pharmacovigilance Practice, International Conference on Harmonization guidelines and Canadian regulatory requirements
- Superb interpersonal skills and attention to detail is required
- Strong organizational skills

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

- GTAA Top Employer Award for 9 years
- Learn about our culture
- Learn more about working with us in Canada
- View our YouTube channel

AstraZeneca is committed to taking every reasonable precaution to protect employees, our customers and the healthcare systems in the communities in which we serve. In an effort to protect the wellbeing of our employees and customers, full COVID-19 vaccination is an essential requirement of all positions at AstraZeneca. As such, all offers of employment will be conditional upon either (i) proof of full COVID-19 vaccination or (ii) proof of need for accommodation under relevant human rights legislation, and AstraZeneca’s determination that the requested accommodation can be provided without undue hardship. You will be required to submit proof of full vaccination or proof of need for accommodation during our background screening process.

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