Medical Director, Senior Patient Safety Physician

ASTRAZENECA UK LIMITED, Luton

Medical Director, Senior Patient Safety Physician

Salary not available. View on company website.

ASTRAZENECA UK LIMITED, Luton

  • Full time
  • Permanent
  • Onsite working

Posted 5 days ago, 19 Apr | Get your application in now to be included in the first week's applications.

Closing date: Closing date not specified

Job ref: dbf98fa5e9fb4b95802fb2b74fb14cea

Location ref: Luton

Full Job Description

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, 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 (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.

  • Medical degree (e.g. MD, MBBS).
  • 2+ years of clinical experience post-registration, industry experience is preferred
  • High level of medical competence, with an ability to balance this with industry standards to achieve business goals.
  • 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
  • MSc/PhD in scientific field
  • Ability to work across TAs and Functions
  • Experience leading and inspiring Patient Safety colleagues
  • 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.

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

    Competitive salary and benefits package on offer. The successful candidate will have access to a flexible employee benefits fund, including holiday purchase and flexible time off, pension contributions, Share Save Plans, A performance recognition scheme and a competitive, generous remuneration package

Direct job link

https://www.jobs24.co.uk/job/medical-director-senior-patient-safety-physician-126712803