Associate Director, Safety Epidemiology, Global Patient Safety
The Role
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 specialisedteam 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 conductingtargeted and systematic literature reviews to support various pharmacovigilance activities to help evaluate potential safety signals, as well as performing statistical analyses onlarge 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 differentrace/ethnic, age and gender categories.
Safety Epidemiology offersa dynamic,inclusive and supportive environment where epidemiologists with a passion for drug safety could thrive in their careers, being able to make ameaningful 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.
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 topicsin 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
WHY JOIN US?
At AstraZeneca we’re dedicated to being a Great Place to Work. Where you are empowered to push the boundaries of science and unleash your entrepreneurial spirit. There’s no better place to make a difference to medicine, patients, and society. An inclusive culture that champions diversity and collaboration, and always committed to lifelong learning, growth, and development. We’re on an exciting journey to pioneer the future of healthcare.
SO, WHAT’S NEXT?
To be considered for this exciting opportunity, please complete the full application on our website at your earliest convenience – it is the only way that our Recruiter and Hiring Manager can know that you feel well qualified for this opportunity. If you know someone who would be a great fit, please share this posting with them.
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 is purposely designed with collaboration in mind, providing space where teams can come together to strategize, brainstorm and connect on key projects.
Great People want to Work with us! Find out why:
Are you interested in working at AZ, apply today!
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 AZCHumanResources@astrazeneca.com.
AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.
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