Associate Director, Safety Epidemiology, Global Patient Safety

at  AstraZeneca

ESSENTIAL REQUIREMENTS

• Ph.D. in pharmacoepidemiology, epidemiology or related health science field and substantial hands-on experience in a research environment
• A strong interest in pursuing a career in pharmacoepidemiology and drug safety
• Able to apply advanced epidemiological theory and techniques to solve new and challenging problems
• Able to conduct targeted and/or systematic literature reviews on drug safety related topics in a timely manner
• Able to provide critical appraisal to study designs and published epidemiological studies
• Able to work effectively with internal & external collaborators, including collaborative groups and contract research organizations (CROs)

DESIRABLE REQUIREMENTS

• PhD dissertation in pharmacoepidemiology or epidemiology with a strong focus on medicines as the exposure of interest
• Prior experience delivering epidemiological studies in a regulatory environment (e.g., PMC/PMRs, PASS etc)
• Hands-on experience in utilizing secondary data and primary data collection studies and knowledge of patient safety databases for use in generating real-world evidence (RWE)
• Effective technical and strategic direction working cross functionally to ensure studies are delivered on time and to a high standard
• Understanding of drug safety and medical terminology and ability to summarize medical information drug safety experience in a clinical or post-marketing environment.
• Lead or advise on characterising the benefit-risk profile of AZ products and/or performing qualitative or quantitative benefit-risk analysis
• Good therapeutic and disease area knowledge and knowledge of drug development and life cycle management
• Knowledge and experience with drug safety reporting and regulatory compliance and experience with international drug safety reporting/regulations, including PASS and RWE studies, Risk Management Plans and Signal Management
• Substantial knowledge and experience in epidemiological methods and research in drug development or in a closely related academic research area

The Safety Epidemiology team within AstraZeneca houses the global team of PhD-trained pharmacoepidemiologists dedicated to the planning and execution of post-authorisation safety studies, intended for submission to various health authorities (e.g., FDA, EMA, etc), being conducted to better understanding the benefit-risk profile of nearly 100 marketed or pipeline products. As the study leads on AstraZeneca’s post-authorisation safety studies, our specialised team of pharmacoepidemiologists are responsible for ensuring that the design, execution, analysis, interpretation, and reporting of these studies are delivered to the highest standards in quality, with regulatory commitments met in a timely manner.
The Associate Director of Safety Epidemiology is a senior scientist and strategic role, accountable for driving scientific and operational aspects of post-authorisation safety studies (PASS) and Post Marketing Commitments (PMCs) utilising RWE, including the use of large electronic healthcare data (EHR) to support various pharmacovigilance and regulatory activities. Other responsibilities include vendor management, broad oversight of requests for epidemiological evidence to support epidemiological input into Risk Management Plans (RMPs), and fulfilling requests for epidemiological evidence needed by the AZ therapy area teams.
Our team of pharmacoepidemiologists are responsible for conducting targeted and systematic literature reviews to support various pharmacovigilance activities to help evaluate potential safety signals, as well as performing statistical analyses on large electronic healthcare data sourced from around the globe. More recently, Safety Epidemiology has been tasked with providing the epidemiological strategy for FDA clinical trial diversity plans and conducting diversity-focused pharmacoepidemiology studies, which help to ensure that AstraZeneca products are both safe and effective across different race/ethnic, age and gender categories.
Safety Epidemiology offers a dynamic, inclusive and supportive environment where epidemiologists with a passion for drug safety could thrive in their careers, being able to make a meaningful and tangible contribution to drug development, pharmacoepidemiology and public health. If you’re a recent graduate of a PhD or post-doctorate programme in epidemiology, with an interest in drug safety and pursuing a career in the pharmaceutical industry, we welcome you to apply.