Job Description

Location: Mississauga, Ontario, Luton, Sweden, or Barcelona

At AstraZeneca, we pride ourselves on crafting a collaborative culture that champions knowledge-sharing, ambitious thinking and innovation \xe2\x80\x93 ultimately providing employees with the opportunity to work across teams, functions and even the globe.

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 and BlueSky Hub in downtown Toronto are purposely designed with collaboration in mind, providing space where teams can come together to strategize, brainstorm and connect on key projects.

Our dedication to sustainability is also central to our culture and part of what makes AstraZeneca a great place to work. We know the health of people, the planet and our business are interconnected which is why we\xe2\x80\x99re taking bold action to solve some of the biggest challenges of our time, from climate change to access to healthcare and disease prevention.

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\xe2\x80\x99re our kind of person.

The Director of Safety Epidemiology is 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) 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.

In this position you 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. You will work closely with cross-functional internal partners across Global Patient Safety, Global Regulatory, Global/Local Medical, and R&D to develop strategic plans for using epidemiological tools and methods. You will also ensure studies are designed and implemented in accordance with the regulatory requirements in anticipation of requests from EMA, FDA and other regulatory agencies. In his role 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.

The Director of 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

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.
• Long and extensive experience working as an epidemiologist in the pharmaceutical industry
• Deep knowledge and experience with drug safety reporting and regulatory compliance and experience with international drug safety reporting requirements and pharmacovigilance regulations
• Previous experience in managing communication with Health Authorities ( e.g.,EMA and FDA)
• Hands-on experience in using 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
• Ability to effectively represent epidemiology and pharmacovigilance operations on multidisciplinary teams
• Experience managing complex medical evidence programmes, including studies such as pragmatic trials or/and PASS
• Able to provide critical appraisal to study designs and published studies
• 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 work effectively with internal & external experts, collaborative groups and contract research organizations (CROs)

Desirable Requirements

• Substantial knowledge and experience in epidemiological methods and research in drug development or in a closely related academic research area
• Good therapeutic and disease area knowledge and knowledge of drug development and life cycle management
• Knowledge of clinical trial activities and reporting requirements
• Experience managing vendors or external research partners

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 .

Date Posted 17-Aug-2023

Closing Date 04-Sept-2023

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.

AstraZeneca