Senior Epidemiologist or Associate Director

Safety Epidemiology team

Hays Life Sciences is now looking to recruit 2 Senior Epidemiologists or Associate Directors for the Safety Epidemiology team for a 1-year contract assignment at AstraZeneca working remotely or in Gothenburg.

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.

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.

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 reporting/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 programs, including studies such as pragmatic trials or/and PASS