Senior Safety Physician
Location:
Gaithersburg , Maryland
Posted:
November 18, 2017
Reference:
R-016963
Location: Gaithersburg, US
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 Senior Safety Physician in Gaithersburg, MD you'll play a pivotal role in channeling our scientific capabilities to make a positive impact on changing patients' lives. GMD (Global Medicines Development) drives late-stage development of our innovative pipeline, transforming exciting science into valued new medicines and ensuring patients around the world can access them.
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 by leveraging novel combinations, biologics and devices. The pipeline also has a number of promising assets in inflammatory and autoimmune diseases within areas such as psoriasis, psoriatic arthritis, gout, systemic lupus and rheumatoid arthritis.
Main Duties and Responsibilities
We are currently seeking a Senior 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-MedImmune 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 rick 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 Requirements
  • Medical degree (MD, MBBS)
  • Some experience of clinical experience post-registration
  • High level of medical competence, with an ability to balance this with industry standards to achieve business goals
  • Relevant experience 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 Requirements
  • 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
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.
AstraZeneca is an equal opportunity employer.  AstraZeneca will consider all qualified applicants for employment without discrimination on grounds of disability, sex or sexual orientation, pregnancy or maternity leave status, race or national or ethnic origin, age, religion or belief, gender identity or re-assignment, marital or civil partnership status, protected veteran status (if applicable) or any other characteristic protected by law. AstraZeneca only employs individuals with the right to work in the country/ies where the role is advertised.

A little about us:
MedImmune is the global biologics research and development arm of AstraZeneca

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