Associate Director, Safety Epidemiology

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

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.

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.

The **Associate** **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.

The incumbent will be responsible for developing and leading global strategy and results 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 partners 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 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 **Associate 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.
- 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 effectively represent epidemiology and pharmacovigilance operations on multidisciplinary teams
- Experience leading 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**:

- Experience working as an epidemiologist in the phar