Associate Director, Safety Epidemiology – Global Patient Safety

Associate Director Safety Epidemiology Global Patient Safety

Location: Luton UK

About AstraZeneca

AstraZenecas Safety Epidemiology team leads the strategy design execution and delivery of postauthorisation 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 decisionmaking benefitrisk assessment and risk management for AstraZeneca products across multiple therapy areas.

Come and join our AZ team where you will play a pivotal role in this exciting period of development!!

The Associate Director Safety Epidemiology is a senior scientific role responsible for the endtoend delivery of complex postauthorisation safety studies using realworld data. The candidate will collaborate across Global Patient Safety Regulatory Affairs Biostatistics Clinical and external partners to produce highquality decisionready 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.

Key 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 rationalise and defend epidemiological approaches with health authorities (e.g. FDA EMA) and ensure regulatory commitments are met with rigor and on time.

• Characterise benefitrisk: Generate and synthesise epidemiological evidence to inform safety profiles support signal assessments and supply qualitative and quantitative benefitrisk 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.

• Coordinate external collaborations: Select lead and mentor CROs and academic partners to ensure methodological quality visibility and reproducibility.

• Conduct literature syntheses: Plan and complete 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.

Impact of the Role

• Patient impact: Evidence produced directly supports regulatory actions and risk minimisation measures that protect patient safety globally.

• Scale and scope: Contributions span nearly 100 products across multiple therapy areas addressing complex and novel safety questions.

• Methodological leadership: Application of advanced methods to complex realworld data to elevate how RWE informs pharmacovigilance and regulation.

• Stakeholder influence: Regular engagement with senior leaders and regulators; findings inform decisions of strategic importance.

Development Opportunities

• Scientific leadership: Build visibility as a subject matter expert in pharmacoepidemiology and RWE for safety.

• Portfolio breadth: Work across diverse therapy areas and data environments (EHR claims registries primary data collection).

• Mentorship and collaboration: Guide external partners and provide input to internal capability building; opportunities to mentor junior scientists.

• External engagement: Publish and present methods and findings; leading to standards for PASS/RWE and diversity in evidence.

Requirements:

• Ph.D. or equivalent in pharmacoepidemiology or epidemiology. Alternatively an MD/PharmD or equivalent with MSc or MPH with experience in a health care environment focusing on RWE studies in the context of regulatory and drug safety

• Strong interpersonal and communication skills to work collaboratively across multiple time zones geographies and business functions

• Experience in pharmacoepidemiology and pharmacovigilance study design and execution

• Experience planning and completing post-authorisation safety studies (PASS) on behalf of Global Markets

• Knowledge and experience with drug safety reporting regulatory compliance and with international requirements and pharmacovigilance regulations

• Hands-on experience in applying secondary data and primary data collection studies and knowledge of patient safety databases for use in generating RWE.

• Ability to apply advanced epidemiological theory and techniques in the context of regulatory and drug safety

• Able to offer detailed evaluation of study builds and published studies

• Understanding of drug safety and medical terminology and ability to summarise medical information drug safety experience in a clinical or post-marketing environment.

• Experience with working internal & external authorities collaborative groups and contract research organisations (CROs)

Desirables:

• 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 supporting RMPs and signal management.

• Handson 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 postmarketing settings.

• 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)

In Office Requirement:

When we put unexpected teams in the same room we unleash bold thinking with the power to inspire life-changing -person working gives us the platform we need to connect work at pace and challenge perceptions. Thats why we work on average a minimum of three days per week from the office. But that doesnt mean were not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world.

Competitive salary and benefits package on offer!

The successful candidate will have access to a flexible employee benefits fund including holiday purchase and flexible time off pension contributions Share Save Plans A performance recognition scheme and a competitive generous remuneration package.

Date Posted

Closing Date