Pharmacoepidemiologist (with Quantitative Focus)

**Location**:Mississauga, Barcelona, or Sweden (hybrid 3 days/week in office)

At AstraZeneca, we pride ourselves on crafting a collaborative culture that champions knowledge-sharing, ambitious thinking and innovation - 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’re taking ambitious action to tackle some of the biggest challenges of our time, from climate change to access to healthcare and disease prevention.

**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 **P**harmacoe**pidemiologist** **is a scientifically-driven vital position, accountable for driving scientific and operational aspects of post-authorisation safety studies (PASS) and post-marketing commitments/requirements (PMCs/PMRs) utilising RWE, including the use of large electronic healthcare data (EHR) to support various pharmacovigilance and regulatory activities.

The incumbent will be responsible for developing and/or 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. They 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 using epidemiological tools and methods. They 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. The incumbent will provide scientific guidance and direction for pharmacoepidemiology, collaborating with colleagues and peers from a wide variety of disciplines to ensure optimal management of relevant studies.

In addition, the pharmacoepidemiologist would have responsibilities over conducting rapid healthcare analytics using large electronic healthcare data using R or through an in-house analytical platform, for the purpose of supporting drug development and/or responding to healthcare authority (e.g., FDA, EMA, etc) requests.

The **P**harmacoe**pidemiologist **must be able to
- Provide strong, detailed guidance for optimizing pharmacoepidemiology and pharmacovigilance study design and execution
- 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
- Leverage large electronic healthcare data to conduct rapid healthcare analytics, using a consultative and problem-solving approach, working under tight deadlines with imperfect information

**Essential Requirements**
- Ph.D. or equivalent in pharmacoepidemiology, epidemiology or related health science field with substantial experience analysing large electronic healthcare data.
- Strong background in epidemiological theory and methods, including appropriate use of medical statistics to solving problems in epidemiology
- Conceptual understanding of secondary data and/or primary data collection studies to design and conduct post-authorisation safety studies
- Able to provide a robust literature review and perform critical appraisals to published studies
- Ability to work effectively with colleagues from a wide variety of disciplines

**Desirable Requirements**
- Prior work experience as a pharmacoepidemiologist or quantitative epidemiologist
- Ability to work independently to achieve specific research objectives
- Experience planning, analysing and interpreting results of statistical analyses performed using large electronic healthcar