Associate Director, Safety Epidemiology

AstraZeneca • Mississauga, ON

58d • Hybrid

About The Position

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.
AstraZeneca’s Safety Epidemiology team leads the strategy, design, execution, and delivery of post‑authorisation safety studies (PASS) across a broad portfolio of marketed and pipeline medicines . We are also responsible and accountable for generating epidemiological insights to investigate safety signals that helps to inform regulatory decision‑making, benefit–risk assessment, and risk management for AstraZeneca products across multiple therapy areas.
The Associate Director, Safety Epidemiology is a senior scientific role responsible for the end‑to-end delivery of complex post‑authorisation safety studies using real‑world data. The candidate will collaborate across Global Patient Safety, Regulatory Affairs, Biostatistics, Clinical, and external partners to produce high‑quality, decision-ready evidence. The role also provides epidemiology strategy and input to key regulatory deliverables, including Risk Management Plans, safety signal evaluations, and diversity plans, to help ensure our medicines are safe and effective for all patients.

Requirements

• PhD in pharmacoepidemiology, epidemiology, or a related health science field, with substantial hands-on research experience.
• 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.
• Independent scientific leadership: Demonstrated ability to scope, design, and deliver end-to-end epidemiologic studies with limited supervision, including setting milestones, managing risks, and driving to decision ready outputs.
• Novel problem solving: Track record of addressing first-of-a-kind or poorly specified safety questions by formulating testable hypotheses, selecting fitforpurpose methods, and iterating solutions based on emerging evidence.
• Decision-making under uncertainty: Experience making timebound, evidence based recommendations when data are incomplete or conflicting, with clear articulation of assumptions, limitations, and risk tradeoffs.
• Methodological agility: Ability to adapt design and analytic strategies (e.g., target trial emulation, advanced confounding control, sensitivity/robustness analyses) to heterogeneous RWD and evolving regulatory expectations.
• Ownership and accountability: Consistent delivery against commitments; anticipates issues, escalates appropriately, and implements corrective actions proactively.

Nice To Haves

• Doctoral research focused on medicines as the exposure of interest and/or safety outcomes.
• Experience delivering epidemiological studies in regulatory contexts (e.g., PASS, PMCs/PMRs) 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 (e.g., protocol drafting support, literature screening and evidence synthesis, data quality checks, and results communication)

Responsibilities

• Lead study strategy and delivery: Direct the design, protocol development, analysis plan, execution, interpretation, and reporting of PASS, PMCs/PMRs, and other pharmacovigilance studies using EHR/claims and other real-world data sources.
• Advance regulatory science: Develop, justify, and defend epidemiological approaches with health authorities (e.g., FDA, EMA) and ensure regulatory commitments are met with rigor and on time.
• Characterise benefit–risk: Generate and synthesise epidemiological evidence to inform safety profiles, support signal assessments, and contribute to qualitative and quantitative benefit–risk evaluations.
• Enable evidence diversity: Lead epidemiology strategies for FDA clinical trial diversity plans and conduct diversity focused real-world evidence analyses across race/ethnicity, age, and gender.
• Oversee external collaborations: Select, manage, and mentor CROs and academic partners to ensure methodological quality, transparency, and reproducibility.
• Conduct literature syntheses: Plan and execute targeted and systematic literature reviews on safety topics and provide critical appraisal with clear recommendations.
• Influence cross functional strategy: Provide authoritative epidemiology input to Global Patient Safety and therapy area teams to inform development and lifecycle decisions.
• Uphold methods and standards: Champion best practices in pharmacoepidemiology, data quality, causal inference, confounding control, and transparent reporting.

Benefits

• Annual Variable Pay Bonus/Short Term Incentive opportunity
• eligibility to participate in our equity-based long-term incentive program (if applicable to role)
• competitive Flex Benefits & Retirement Savings Program
• 4 weeks’ paid vacation
• annual Personal Days

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: Ph.D. or professional degree
• Number of Employees: 5,001-10,000 employees