Patient Safety Associate
1 month ago
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.
In this position, you will be responsible for the conduct of Pharmacovigilance activities for AstraZeneca Canada to ensure compliance with company and regulatory requirements:
**Responsibilities**:
- Ensure data accuracy, follow-up and reconciliation is completed on pharmacovigilance cases in accordance with program requirements (for e.g.: Canada Vigilance, Market Research Programs, Early Access Programs, local studies)
- Maintain well-documented files for processed cases to provide an audit trail and satisfy requirements of any regulatory inspection, local and global AZ audits
- Escalate potential safety issues or concerns to Patient Safety Manager (or other Patient Safety personnel, as applicable) which may have medical, regulatory, legal or other consequences and thus, managed in accordance with procedures
- Maintain basic knowledge of disease and therapeutic area, and Health Canada regulations
- Ensure reconciliations with interfaces who shall receive potential adverse events (i.e. Medical Information, Quality complaints)
- Reviews potential adverse events from other repository/information sources
- Streamline or participate in the review of local procedures and processes.
- Perform retrospective QA/QC reviews of AE reports processed by case handling vendor
- Monitor Patient Safety mailbox and triage as applicable
- Monitor and process late logs in the local safety database
- Facilitate and participate in vendor management activities such as vendor meetings, agenda, audits, track the status of action items, CAPA management, escalate issues to manager as appropriate
- Ensure Clinical Study global list reconciliation with local study project tracker
- Review and process queries from Global Patient Safety and Health Canada
**Qualifications**:
- Post Secondary Education is required. College Diploma and/or University Degree in a health related area of study preferred.
- 2 - 3 years working knowledge of Pharmacovigilance processes.
- Knowledge of medical terminology.
- Thorough understanding of SOPs, GVP, ICH guidelines and Regulatory Requirements.
- Ability to speak French is an asset.
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
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