Safety Physician - RIA - PI
AstraZeneca has an opening for Safety Physicianin Gaithersburg, MD or Waltham MA
Are you ready to drive development of our innovative Respiratory and Immunology pipeline? AstraZeneca holds a unique position in Respiratory Disease, including asthma, chronic obstructive pulmonary disease (COPD) and idiopathic pulmonary fibrosis (IPF), with a range of differentiated potential medicines in development, leveraging novel combinations, biologics and devices.
At AstraZeneca we work together across global boundaries to make an impact and find answers to challenges. We do this with the upmost 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 exceptional skills with those of people from all over the globe. As a Safety Physician in Gaithersburg, MD or Waltham MA you’ll play a pivotal role in channeling our scientific capabilities to make a positive impact on changing patients’ lives, transforming exciting science into valued new medicines and ensuring patients around the world can access them.
Our Gaithersburg, Maryland facility creates life-changing medicines for people around the world. This campus employs more than 3,500 experts in our field and is only a short drive from Washington, DC. This modern and vibrant scientific campus is the home of R&D and Oncology in the US. Here, we play host to some of the most cutting-edge technology and lab spaces, all designed to inspire collaboration and cross-functional science. We believe employees benefit from being challenged and inspired at work. We are dedicated to creating a culture of inclusion and collaboration.
The Gaithersburg site offers a variety of amenities to help boost productivity and help keep our employees happy and healthy. This includes a fitness center, employee healthcare clinic, electric vehicle charging stations, dry cleaning, full-service cafeteria and copy center. This is where you’ll find newly-designed, activity-based work spaces to suit a variety of working styles while increasing collaboration between teams.
The Chief Medical Office (CMO ) is an integrated, enterprise-wide organization dedicated to defining the benefit/risk assessment of our medicines across the life-cycle, acquiring and maintaining their health authority approvals around the world, and ensuring they are accessible for patients.The CMO mission is :-
- Provide a scientific and strategic perspective on the safe development, maintenance and use of our medicines
- Foster a culture of continuous improvement and quality, defining global standards for medical and scientific activities
- Ensure consistent strategic, technical and operational regulatory support across the enterprise
- Be a trusting, inclusive and innovative organization, that attracts, develops and retains the best and brightest
- Advocate the patient perspective on the development and ethical use of our medicines
What you’ll do
We are currently seeking a Safety Physician to join our Respiratory Disease Global Patient Safety Team. In this role, you will be responsible for the Clinical Safety strategy for assigned AstraZeneca drug projects and products throughout all stages of development and/or when on the market, including implementation and communication of the strategy at the cross-functional project team level. This will include continued safety assessment, evaluation and risk management. You will be involved in all safety surveillance activities, including medical review of individual safety cases (providing medical expertise and judgement), signal detection, evaluation and safety evaluation and risk management activities for all products in your area of responsibility. You will provide medical input and review of periodic reports and renewal documentation submitted to regulatory agencies and will lead the patient safety contribution to global regulatory submissions for new products, formulations or indications.
Essential for the role
- Medical degree (MD, MBBS)
- At least 2 years of clinical experience post-registration
- High level of medical competence, with an ability to balance this with industry standards to achieve business goals
- At least 5 years of Drug Development/Patient Safety experience (either within the industry or as a clinical investigator for drug trials) with clear evidence of delivery
- A thorough knowledge of the pharmaceutical/ biopharmaceutical industry, especially clinical research and global regulatory requirements (BLA, NDA or MAA) and practices governing expedited and periodic safety reporting, signal generation, safety evaluation and risk management activities
Desirable for the role
- MSc/PhD in scientific discipline
- Able to work across therapeutic areas and functions
- Experience in respiratory disease is strongly preferred
- Experience of supervising Patient Safety colleagues
- A demonstrated ability to understand epidemiological data
At AstraZeneca when we see an opportunity for change, we seize it and make it happen, because any opportunity no matter how small, can be the start of something big. Delivering life-changing medicines is about being entrepreneurial - finding those moments and recognising their potential. Join us on our journey of building a new kind of organisation to reset expectations of what a bio-pharmaceutical company can be. This means we’re opening new ways to work, pioneering cutting edge methods and bringing unexpected teams together. Interested? Come and join our journey.
So, what’s next!
Are you already imagining yourself joining our team? Good, because we can’t wait to hear from you. Join AstraZeneca and help us deliver life changing medicines. Be among our employees who continue to make us an innovation-driven company that stands firmly among the leaders in biopharmaceuticals.
Next Steps – Apply today!
To be considered for this exciting opportunity, please complete the full application on our website at your earliest convenience – it is the only way that our Recruiter and Hiring Manager can know that you feel well qualified for this opportunity. If you know someone who would be a great fit, please share this posting with them.
Where can I find out more?
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AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorisation and employment eligibility verification requirements.