Pharmacoepidemiologist, Safety Epidemiology, Global Patient Safety

at  AstraZeneca

ESSENTIAL REQUIREMENTS:

• Ph.D. in pharmacoepidemiology, epidemiology, or a related health science field, with substantial hands-on experience in a research environment.
• Strong interest in pursuing a career in pharmacoepidemiology and drug safety.
• Ability to apply advanced epidemiological theory and techniques to solve new and challenging problems.
• Proficiency in conducting targeted and/or systematic literature reviews on drug safety-related topics in a timely manner.
• Ability to critically appraise study designs and published epidemiological studies.
• Effective collaboration with internal and external partners, including collaborative groups and contract research organizations (CROs).

DESIRABLE REQUIREMENTS:

• PhD dissertation focused on pharmacoepidemiology or epidemiology with a strong emphasis on medicines as the exposure of interest.
• Hands-on experience with secondary data and primary data collection studies, and knowledge of patient safety databases for generating real-world evidence (RWE).
• Understanding of drug safety and medical terminology, with the ability to summarize medical information and drug safety experience in a clinical or post-marketing environment.
• Good therapeutic and disease area knowledge, along with an understanding of drug development and life cycle management.
• Experience with drug safety reporting and regulatory compliance, including international regulations related to PASS, RWE studies, Risk Management Plans, and Signal Management.
• Substantial knowledge and experience in epidemiological methods and research in drug development or a closely related academic field.

The Safety Epidemiology team within AstraZeneca consists of a global group of PhD-trained pharmacoepidemiologists dedicated to planning and executing post-authorisation safety studies (PASS) for nearly 100 marketed or pipeline products. These studies are intended for submission to various health authorities (e.g., FDA, EMA) to better understand the benefit-risk profile of these products. As project leads on AstraZeneca’s PASS, our specialized team ensures that the design, execution, analysis, and reporting of these studies adhere to the highest scientific standards and are delivered in a timely manner.
In addition to post-authorisation safety studies, Safety Epidemiology is responsible for performing targeted and systematic literature reviews to support various pharmacovigilance activities, evaluating potential safety signals, and conducting rapid data analytics on large electronic healthcare datasets sourced globally. Recently, Safety Epidemiology has also been tasked with setting the epidemiological strategy for FDA clinical trial diversity plans and conducting diversity-focused pharmacoepidemiology studies in support of regulatory submissions. This work helps ensure that AstraZeneca products are safe and effective across different race/ethnicity, age, and gender categories.
Safety Epidemiology offers a dynamic, inclusive, and supportive environment where epidemiologists passionate about drug safety can thrive in their careers, making meaningful contributions to drug development, pharmacoepidemiology, and public health. If you’re a recent PhD or post-doctorate graduate in epidemiology with an interest in drug safety and a desire to pursue a career in the pharmaceutical industry, we welcome you to apply.