Medical Director, Senior Patient Safety Physician

At AstraZeneca we work together across global boundaries to make an impact and find answers to challenges. We do this with integrity even in the most difficult situations because we are committed to doing the right thing. We continuously forge partnerships that help pursue world-class medicines in new ways, combining our people's outstanding skills with those of people from all over the globe!

AstraZeneca's vision is to help patients by redefining the treatment paradigm, with a broad pipeline of next-generation medicines. We're investing to enhance our understanding of disease as we work towards creating the next generation of therapeutics and pioneering new approaches to better predict clinical outcomes. We harness digital, data science & AI to fast-forward our research. Making sure work born in a lab can make a real difference. Working here means that every day you will be impacting patients' lives across the world.

AstraZeneca, Global Patient Safety (GPS) is at the forefront of defining and optimizing the safety profile of our medicines across their lifecycle in all therapeutic areas. GPS leads the way in integrating science, data, and technology to shape clinical safety strategies. From monitoring and detection to characterization and reporting of adverse events, GPS plays a critical role in ensuring the safety of our medicines for patients worldwide.

As a Medical Director, Senior Patient Safety Physician in Patient Safety BioPharma, you'll play a pivotal role in channeling our scientific capabilities to make a positive impact on changing patients' lives. BioPharma Global R&D drives our innovative pipeline, redefining science into valued new medicines and ensuring patients around the world can access them.

Main Duties and Responsibilities:

In this role, you'll be responsible for the Clinical Safety strategy for assigned drug projects and products throughout all stages of development and/or when on the market, including implementation and communication of the strategy at the project team/governance level. Essentially, the continued safety assessment, evaluation and risk management of AZ products or product groups in various stages of clinical development and/or the post-marketing setting as well as the continuous efficient evaluation of adverse event and all other safety information will be within the remit and scope of this role.

You will provide consistent communication of safety topics across all regulatory safety documents, e.g. Periodic Benefit Risk Evaluation Reports (PBRERs), Periodic Adverse Drug Experience Reports (PADERs) and Development Safety Update Reports (DSURs), for assigned product(s)/program(s).

You will proactively evaluate the clinical implications of safety data from pre-clinical studies, clinical studies, literature to predict / establish the safety profile of compounds in clinical development. This process includes employing expert groups and methodologies such as Safety Knowledge Groups (SKG's), Safety Science, Informatics expertise, modeling and simulation to manage the risk to patients. Additionally, you'll be involved in all safety surveillance activities, that may include medical review of individual safety cases (providing medical expertise and judgment), signal detection, evaluation and safety information review committee activities for all products in area of responsibility.

This role will also require your medical input and review of periodic reports (e.g. PBRERs, PSURs, or DSURs) and renewal documentation submitted to regulatory agencies and the patient safety contribution to global regulatory submissions (NDA, BLA, MAA etc.) for new products, formulations or indications.

Essential Education, Experience and Skill Requirements

* Medical degree (e.g. MD, MBBS).
* High level of medical competence, with an ability to balance this with industry standards to achieve business goals.
* Scientific track-record in a specialty relevant to PSTA Biopharma.
* At least 3+ years of clinical experience in a specialty relevant to PSTA Biopharma.
* Ability to work effectively in an advanced matrix structure.
* Proficient in written and verbal English.



Preferred Education, Experience and Skills

* PhD in scientific field relevant to PSTA Biopharma.
* Experience managing and coaching peers (e.g as a line manager and/or leading a research team).
* Documented experience as Principal Investigator in clinical trials or at least 2+ years of Drug Development/Patient Safety experience with clear evidence of delivery.
* Scientific expertise in cardiovascular medicine or a closely related field.



Location: Onsite 3 days/week in Gothenburg, Sweden

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.

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 already envisioning yourself joining our team? Good, because we can't wait to hear from you! We will be reviewing applications and shortlisting on a rolling basis - as such we reserve the right to withdraw this vacancy ahead of the stated closing date