Senior Medical Director, Principal Patient Safety Physician

Do you have expertise in and a passion for Patient Safety? Would you like to apply your expertise to provide medico-scientific and clinical strategic leadership 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 we turn ideas into life changing medicines. 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.

Patient Safety BioPharma at AstraZeneca is now looking for a Senior Medical Director, Principal Patient Safety Physician to join our team in Gothenburg, Sweden.

The core purpose of Patient Safety is to add value to AstraZeneca products, provide clear science based guidance for investigators and prescribers to safeguard patients as well as the success of our business. Patient Safety covers the entire clinical life cycle of a drug from first time into man to withdrawal of a product from the market.

What you'll do
As a Senior Medical Director, Principal 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 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:

* Provision of 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.
* Expert input to all elements of design and interpretation, including efficient use of tools and methodology (e.g. modelling and simulation).
* Leadership to support project discussions with governance boards, including interactions with Patient Safety Peer Review Committee.
* Leading the safety strategy for regulatory communication and provide oversight of high-level documents to support submission activities.
* Medico-scientific contributions to RMPs for assigned products and to Periodic Reports, including PBRERs and 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 collaborators.

Essential for the role

* Medical Degree, experience from clinical practice and extensive experience from pharmaceutical industry R&D work
* Relevant experience in Pharmacovigilance field from pharma industry, Regulatory Agency or Public Health Agency
* A broad understanding about Health Authority regulations and Good Clinical Practice Standards and experience from working with safety evaluation and risk management
* Experience in designing, monitoring and implementing clinical trials and interpreting trial results
* Strategic leadership of complex drug projects
* Shown 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 field
* Therapeutic area expertise and commercial understanding
* Extensive general medical knowledge
* 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.

When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working gives us the platform we need to connect, work at pace and challenge perceptions. That's why we work, on average, a minimum of three days per week from the office. But that doesn't mean we're not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world.

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.