Director, Principal Patient Safety Scientist
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.
Introduction to role
The Director, Principal Patient Safety Scientist role provides expertise to multiple and/or single but complex products in different stages of development as needed. You will provide oversight of safety documents and deliverables for these projects in collaboration with the Global Safety Physician (GSP) and other PV Scientists. You will lead PV strategy for safety documents and regulatory reports.
Accountabilities
• Lead the strategy for proactive pharmacovigilance and risk management planning of complex or multiple products, including preparation of the safety aspects of Global Risk Management Plans and Risk Evaluation and Mitigation Strategies (REMS) in partnership with the GSP and others as appropriate.
• Provide subject matter expertise in the therapeutic area and across multiple products.
• Lead cross-functional process improvement or other initiatives on behalf of the Patient Safety organization.
• Perform duties as a Safety Strategy and Management Team (SSaMT) Leader for complex and/or multiple products.
• As a Safety expert, lead presentation of complex issues to Safety Information Review Committee (SIRC).
• Lead safety strategy for multiple or complex periodic regulatory documents (PBRERs, PSURs, DSURs) according to the agreed process and timelines.
• Lead safety strategy for regulatory submissions of new products, formulations or indications (NDA/BLA, MAA), in partnership with the GSP and other functional experts.
• Lead negotiations and provide expertise to the PS component of contracts/agreements with third parties to ensure quality and integrity of agreements.
• Take accountability and lead resolution of complex safety issues and mediate cross-functional agreement.
• Participate in due diligence activities.
• As a safety expert, provide training and mentorship to new GSPs and PV Scientists in approved processes and systems.
Essential Skills/Experience
• A life sciences/pharmacy/nursing degree, and advanced Patient Safety and/or Clinical/ Drug Development experience (Submission experience is a must)
• Fluent in written and verbal English
• Advanced knowledge of PV regulations
Desirable Skills/Experience
• MD/MSc/PhD in scientific discipline, preferred
• Advanced understanding of epidemiology, preferred
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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.
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