Director Safety Epidemiology

hace 2 semanas

Barcelona, España AstraZeneca A tiempo completo

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 **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 stakeholders 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 utilizing 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 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

**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 mean

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