Senior Epidemiologist or Associate Director, Safety Epidemiology

Job description
Do you have expertise in, and passion for drug safety and real world evidence (RWE)? Would you like to apply your expertise to evaluate the safety of medicines in a company that follows the science and turns ideas into life changing medicines? Then AstraZeneca might be the one for you! At AstraZeneca, we put patients first and strive to meet their unmet needs worldwide. Working here means being entrepreneurial, thinking big and working together to make the impossible a reality. If you are swift to action, confident to lead, willing to collaborate, and curious about what science can do, then you’re our kind of person.

Why AstraZeneca?
At AstraZeneca when we see an opportunity for change, we seize it and make it happen, because any opportunity no matter how small, can be the start of something big. Delivering life-changing medicines is about being entrepreneurial - finding those moments and recognizing their potential. Join us on our journey of building a new kind of organization to reset expectations of what a bio-pharmaceutical company can be. This means we’re opening new ways to work, pioneering cutting edge methods and bringing unexpected teams together. Interested? Come and join our journey. Are you already imagining yourself joining our team? Good, because we can’t wait to hear from you.

Responsibilities
The Senior Epidemiologist or Associate Director works independently in the design, execution, analysis, interpretation, and internal and external communication of specific epidemiological studies and literature reviews. This role requires taking a leadership role in a range of activities, including delivery of experienced epidemiology strategy, support, and scientific leadership to project teams and the epidemiology global skills group, at all stages of pharmaceutical development.

They will manage externally commissioned research projects, which includes establishing, maintaining, and expanding relationships to partner effectively with external experts and research groups to negotiate time frames, provide recommendations on resource requirements, and ensure delivery of the tasks as agreed. They will promote good epidemiological practice and represents the company’s position when interacting with external experts, collaborative groups, and contract research organizations; and will keep abreast of epidemiological developments within academia, regulatory, and among key opinion leaders.

Qualifications
Essential Requirements:
Ph.D. or equivalent in pharmacoepidemiology, epidemiology or related health science field and substantial experience in the health care environment. Alternatively, an MSc or MPH with consolidated experience in the health care environment.
Hands-on experience in utilizing 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
Able to provide critical appraisal to study designs and published studies
Ability to work effectively with internal & external experts, collaborative groups and contract research organizations (CROs)

Desirable Requirements:
A broad global pharmacovigilance knowledge including knowledge of PASS studies, post-marketing commitments and reporting requirements
Understanding of drug safety and medical terminology and ability to summarize medical information drug safety experience in a clinical or post-marketing environment.
Ability to effectively represent epidemiology and pharmacovigilance operations on multidisciplinary teams
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 eporting/regulations, including PASS and RWE studies, Risk Management Plans and Signal Management
Previous experience in managing communication with EMA and FDA
Substantial knowledge and experience in epidemiological methods and research in drug development or in a closely related academic research area
Knowledge of clinical trial activities and reporting requirements
Experience managing complex medical evidence programmes, including studies such as pragmatic trials or/and PASS


Application
Deadline 2021-11-10,  selection and interviews will be ongoing. The position may be filled before the last day of application, therefore, apply as soon as possible.


For more information: Kerstin Karlsson kerstin.karlsson@randstad.se or Veronika Knudsen veronika.knudsen@randstad.se

About the company
Randstad Life Sciences specializes in the field of science and is part of Randstad, the world leader in recruitment and consulting with operations in 38 countries. With this global network, in combination with our strong local foundation, we can offer a wide range of varied and developing assignments and jobs for you who are a specialist in life science. Our mission is to help you reach your true potential with your career in focus!