Pharmacoepidemiologist, Safety Epidemiology Luton, East of England, England
Job description
Location: Mississauga, Luton, or Barcelona (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.
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.
The Pharmacoepidemiologist, Safety Epidemiology is a scientifically driven vital position, accountable for driving scientific and operational aspects of post-authorization safety studies (PASS) and Post Marketing Commitments (PMCs) applying 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 successful candidate 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 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 crafted 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 subject areas to ensure efficient management of relevant studies.
Responsibilities:
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.
Contribute to characterizing the benefit-risk profile of AZ products and/or performing qualitative or quantitative benefit-risk analysis
Requirements
Ph.D or equivalent in pharmacoepidemiology, epidemiology or related health science field. Alternatively, a MSc or MPH with validated experience in pharmacoepidemiology.
Strong background in epidemiological theory and methods, including appropriate use of medical statistics to solving problems in epidemiology
Able to provide a robust literature review and perform critical appraisals to published studies
Conceptual understanding of secondary data and/or primary data collection studies and they can be used to generate RWE.
Ability to work effectively with experts from a wide variety of subject areas
Desirable Requirements:
Prior work experience as an epidemiologist
Extensive 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
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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 [email protected].
