Pharmacoepidemiologist

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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 for nearly 100 marketed or pipeline products. As the project leads on AstraZenecas post-authorisation safety studies (PASS) our specialised team of pharmacoepidemiologists are responsible for ensuring that the design execution analysis and reporting of these studies are conducted under the highest scientific standards and 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 to help evaluate potential safety signals as well as performing rapid data analytics on large electronic healthcare data sourced from around the globe. More recently Safety Epidemiology has been tasked with setting the epidemiological strategy for FDA clinical trial diversity plans and conducting diversity-focused pharmacoepidemiology studies in support of regulatory submissions which help to 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 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 youre 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.

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

• 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)

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

• 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

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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.

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