Patient Safety Physician - RIA
Company: AstraZeneca
Location: Gaithersburg
Posted on: January 15, 2021
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Job Description:
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 medicinesFoster a culture of continuous
improvement and quality, defining global standards for medical and
scientific activitiesEnsure consistent strategic, technical and
operational regulatory support across the enterpriseBe a trusting,
inclusive and innovative organization, that attracts, develops and
retains the best and brightestAdvocate the patient perspective on
the development and ethical use of our medicinesWhat you---ll doWe
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 roleMedical degree (MD, MBBS)At least 2 years of clinical
experience post-registrationHigh level of medical competence, with
an ability to balance this with industry standards to achieve
business goalsAt 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 deliveryA
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 activitiesDesirable for the roleMSc/PhD in
scientific disciplineAble to work across therapeutic areas and
functionsExperience in respiratory disease is strongly
preferredExperience of supervising Patient Safety colleaguesA
demonstrated ability to understand epidemiological dataWhy
AstraZeneca?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 todayTo 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?Our Social Media, Follow AstraZeneca on LinkedIn Follow
AstraZeneca on Facebook Follow AstraZeneca on Instagram Date
Posted11-Jan-2021Closing Date30-Jan-2021AstraZeneca 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 authorization and employment eligibility verification
requirements.Full time
Keywords: AstraZeneca, Washington DC , Patient Safety Physician - RIA, Healthcare , Gaithersburg, DC
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