Senior Medical Director, Principal Patient Safety

hace 7 meses

Barcelona, España AstraZeneca A tiempo completo

Location: Barcelona, Spain (on-site)

AstraZeneca is a global, science-led, patient-focused biopharmaceutical company that focuses on the discovery, development and commercialisation of prescription medicines for some of the world’s most serious diseases. But we’re more than one of the world’s leading pharmaceutical companies.

Working with one of the broadest and deepest Oncology pipelines in the industry offers the possibility to work on the most novel molecules at all development stages. It takes each of us challenging our thinking to keep pushing our pipeline forward and shape the future of Oncology.

**What you'll do**

As an Senior Medical Director, Patient Safety Physician, you are a senior leader within Patient Safety and play a key role bringing deep clinical understanding and judgement in benefit risk assessments for AstraZeneca products. You also have a role in shaping the culture of the department; and will act as a coach and mentor to more junior Patient Safety staff. You will also ensure projects adhere to Good Clinical and Pharmacovigilance Practice and regulatory requirements. We encourage you to closely follow medical developments within assigned areas to incorporate emerging data and trends into the safety strategy

**Your duties and responsibilities are likely to include**:
You will provide medico-scientific and clinical strategic leadership for assigned product(s).
- Providing strategic Patient Safety input to drug development and post-marketing programs
- Collaboration with team members to undertake safety surveillance activities and prepare high quality evaluation documents to describe safety findings.
- Ensuring expert input to all elements of design and interpretation, including efficient use of tools and methodology (e.g. modelling and simulation).
- Providing leadership to support project discussions with governance boards, including interactions with Patient Safety Peer Review Committee.
- Lead the safety strategy for regulatory communication and provide oversight of higher-level documents to support submission activities.
- Lead medico-scientific contributions to RMPs for assigned products and to Periodic Reports, including PBRERs, DSURs.

More broadly you are expected to participate in advisory discussions to support other Patient Safety teams in the development of their safety strategy and may be asked to represent Patient Safety in cross-functional discussions with internal and external stakeholders.

**Essential for the role**
- Degree in medicine and experience as a physician or academic clinician
- Extensive experience in Pharmacovigilance, with clear evidence of delivering to a high standard
- Detailed understanding of pharmaceutical safety, reporting and surveillance processes and strong experience of Patient Safety, as it relates to clinical trials and marketed products in any relevant field such as pharma, Regulatory Agency or Public Health agency
- Experience in designing, monitoring and implementing clinical trials and interpreting trial results
- Strategic leadership of complex drug projects
- Understanding of the medico-legal aspects of pharmacovigilance
- Proven leader of cross-functional delivery teams.
- Demonstrated ability to influence key business partners within and outside of company
- Proficiency with both written and verbal communications

**Desirable for the role**
- PhD in scientific discipline
- Therapeutic area expertise and commercial understanding
- Extensive general medical knowledge
- Able to work across TAs and Functions
- Research background, including peer reviewed publications

**Why AstraZeneca?**

At AstraZeneca we’re dedicated to being a Great Place to Work. Where you are empowered to push the boundaries of science and unleash your entrepreneurial spirit. There’s no better place to make a difference to medicine, patients and society. An inclusive culture that champions diversity and collaboration, and always committed to lifelong learning, growth and development. We’re on an exciting journey to pioneer the future of healthcare.

**So, what's next?**

Are you ready to bring new ideas and fresh thinking to the table? Brilliant We have one seat available and we hope it’s yours.

**Where can I find out more?

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