Job Title: Medical Director, Patient Safety Physician
Location: 3 days onsite in Luton UK
Are you ready to lead patient safety innovation at the forefront of global healthcare? At AstraZeneca, we're not just developing tomorrow's medicines—we're reimagining how patient safety shapes every breakthrough. As a Medical Director and Patient Safety Physician in our vibrant Luton hub, you'll join a collaborative network of world-class professionals who turn complex challenges into life-changing solutions. Here, your expertise doesn't just protect patients; it drives the strategic decisions that bring hope to millions worldwide. We believe that exceptional patient safety requires exceptional minds working together across continents, combining cutting-edge science with unwavering integrity to ensure every innovation serves humanity's greatest need: safe, effective treatments that transform lives!
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, 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, modelling 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 SERM activities for all products in area of responsibility.
This role will also require your medical input and review of periodic reports ( 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
1. Medical degree ( MD, MBBS).
2. 2+ years of clinical experience post-registration,
3. High level of medical competence, with an ability to balance this with industry standards to achieve business goals.
4. 2+ years of Drug Development/Patient Safety experience (the majority of which should be in industry in Patient Safety) with clear evidence of delivery.
Preferred Education, Experience and Skills
5. Higher Medical Training in Pharmaceutical Medicine
6. MSc/PhD in scientific field
7. Ability to work across TAs and Functions
8. Experience leading and inspiring Patient Safety colleagues
9. A demonstrated ability to understand epidemiological data
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.
At AstraZeneca, patient impact drives every decision: a broad and rapidly evolving Oncology pipeline offers constant exposure to novel mechanisms, complex data and innovative trial designs; cross-functional collaboration with global experts fuels learning; a culture that values courage, curiosity and smart risk-taking empowers decisive action based on science; and continuous development opportunities support long-term growth while contributing directly to transforming cancer care worldwide.