Director, Safety Epidemiology
Title:Director, Safety Epidemiology
Location: Cambridge, UK | Gaithersburg, US | Gothenburg, Sweden
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.
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 Director, Safety Epidemiology is newly created role in AstraZeneca and a scientifically driven vital position, 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) for AstraZeneca’s Cardiovascular, Vascular, Renal and Metabolism Franchise (CVRM).
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.
The incumbent will be responsible for developing and leading global strategy and deliverables across various products in the AZ Biopharmaceuticals portfolio and will also support and coordinate with local markets on mandated PASS requiring local RWE data. In this role, the incumbent will work closely with cross-functional internal stakeholders across Global Patient Safety , Global Regulatory, Global/Local Medical, and R&D to develop strategic plans for epidemiology and global pharmacovigilance studies. The incumbent will then ensure studies are designed and implemented in accordance with the regulatory requirements in anticipation of requests from EMA, FDA and other regulatory agencies.
The Director, Safety Epidemiology must be able to
- provide strong, detailed guidance for optimizing pharmacoepidemiology and pharmacovigilance study design and execution
- effective technical and strategic direction working cross functionally to ensure studies are delivered on time and to a high standard
- develop design and drafting of protocols and a broad range of observational research including primary data collection and secondary use of data
- conduct ad hoc literature reviews on Patient Safety related RWE and related matters and provides epidemiological input for CRF development.
- lead or advise on characterising the benefit-risk profile of AZ products and/or performing qualitative or quantitative benefit-risk analysis
The Director works directly with Patient Safety, Medical and Regulatory teams to enable efficient ways of working and ensure that existing and future SOPs related to epidemiology and pharmacovigilance are suited to successfully meet the needs of relevant studies. You will be the go-to person to provide scientific guidance and direction for pharmacoepidemiology, including senior leaders, and collaborate with senior colleagues and peers to ensure optimal management of relevant studies.
- Experience working as an epidemiologist in the pharmaceutical industry
- Ability to effectively represent the Safety Epidemiology team on multidisciplinary teams within a pharmaceutical company
- 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 throughout the product life cycle
- Experience managing complex medical evidence programmes in PASS
- 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)
- Experience managing vendors or external research partners
- Good therapeutic and disease area knowledge and knowledge of drug development and life cycle management
- A broad global pharmacovigilance knowledge including knowledge of PASS studies, post-marketing commitments and reporting requirements
- 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
- Understanding of drug safety and medical terminology and ability to summarize medical information drug safety experience in a clinical or post-marketing environment.
- 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
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 authorisation and employment eligibility verification requirements.