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 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

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 minimization effectiveness. You will also spearhead the authoring of REMS assessment reports, analyzing 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

• PhD in pharmacoepidemiology, epidemiology, or a related health science field, with substantial hands-on research experience.

• Proven experience in designing and delivering research studies, including primary data collection and analysis.

• Demonstrated ability to apply advanced epidemiological methods to complex, real-world safety questions.

• Proven experience conducting targeted and/or systematic literature reviews and providing critical appraisal of epidemiological studies.

• Strong collaborator with experience working across internal teams and with external partners (e.g., CROs, academic groups).

• Excellent written and oral communication skills with the ability to translate complex methods and results into decision-ready insights.

• Prior experience with REMS, RMPs or post-market surveillance strongly preferred.

• Independent scientific leadership: Demonstrated ability to scope, design, and deliver end-to-end epidemiologic studies with limited supervision.

• Novel problem solving: Track record of addressing first-of-a-kind or poorly specified safety questions by formulating testable hypotheses.

• Decision making under uncertainty: Experience making time-bound, evidence-based recommendations when data are incomplete or conflicting.

• Methodological agility: Ability to adapt design and analytic strategies to heterogeneous RWD and evolving regulatory expectations.

• Ownership and accountability: Consistent delivery against commitments; anticipates issues and implements corrective actions proactively.

Desirable Skills/Experience

• Doctoral research in pharmacoepidemiology focused on medicines as the exposure of interest and/or safety outcomes.

• Experience delivering epidemiological studies in regulatory contexts and contributing to RMPs and signal management.

• Hands-on experience with secondary data (EHR/claims/registries) and primary data collection; familiarity with patient safety databases.

• Experience shaping study strategy and operations to deliver on time and to a high standard.

• Working knowledge of drug safety and medical terminology; experience summarising safety information in clinical or post-marketing settings.

• Experience contributing to benefit–risk assessments (qualitative and/or quantitative).

• Understanding of global safety regulations and RWE expectations from health authorities.

• Broad disease area knowledge and understanding of drug development and lifecycle management.

• Familiarity with the use of AI/ML tools to enhance day-to-day workflows and study delivery.

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Are you interested in working at AZ, apply today!

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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Date Posted

29-Sept-2025

Closing Date

06-Oct-2025

AstraZeneca embraces diversity and equality of opportunity.  We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills.  We believe that the more inclusive we are, the better our work will be.  We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics.  We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.

AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorisation and employment eligibility verification requirements.