Associate Director, Safety Epidemiology & Risk Evaluation Mitigation Strategies

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 strategise, 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 are taking ambitious action to tackle some of the biggest challenges of our time, from climate change to access to healthcare and disease prevention.

Join AstraZeneca's Safety Epidemiology team where we lead the charge in shaping the strategy, design and execution of post‑authorisation safety studies (PASS) for a diverse range of marketed and pipeline medicines. As the Associate Director Safety Epidemiology & Risk Evaluation Mitigation Strategies you will play a pivotal role in overseeing the effectiveness of the AstraZeneca / Alexion US REMS. Your expertise will guide the evaluation of key performance indicators such as enrollment rates and compliance metrics ensuring risk minimisation effectiveness. You will also spearhead the authoring of REMS assessment reports, analysing and interpreting their effectiveness across various domains. Collaborating with Global Patient Safety, Regulatory Affairs, Biostatistics, Clinical teams and external partners you will deliver high‑quality decision‑ready evidence. Your contributions will be integral to regulatory deliverables including Risk Management Plans and safety signal evaluations.

Accountabilities

• Lead US Risk Evaluation and Mitigation Strategy (REMS) Effectiveness evaluations : Lead the evaluation and interpretation of KPIs.
• Lead study strategy and delivery : Direct the design, protocol development, analysis plan execution, interpretation and reporting of PASS and other pharmacovigilance studies using real‑world data sources.
• Advance regulatory science : Develop and defend epidemiological approaches with health authorities to ensure regulatory commitments are met.
• Uphold methods and standards : Champion best practices in pharmacoepidemiology and transparent reporting.
• Influence cross‑functional strategy : Provide authoritative epidemiology input to inform development and lifecycle decisions.
• Oversee external collaborations : Manage CROs and academic partners to ensure methodological quality and reproducibility.

Essential Skills / Experience

Desirable Skills / Experience

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

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 .

#LI‑Hybrid

Date Posted : 29‑Sept‑2025

Closing Date : 06‑Oct‑2025

#J-18808-Ljbffr