AstraZeneca Pharmaceuticals LP Senior Safety Physician in Gaithersburg, Maryland
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’s vision in Oncology is to help patients by redefining the cancer-treatment paradigm, with the aim of bringing six new cancer medicines to patients between 2013 and 2020. A broad pipeline of next-generation medicines is focused principally on four disease areas - breast, ovarian, lung and hematological cancers. As well as other tumor types, these are being targeted through four key platforms - immunotherapy, the genetic drivers of cancer and resistance, DNA damage repair, and antibody drug conjugates, underpinned by personalized healthcare and biomarker technologies.
Main Duties and Responsibilities
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.
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 2 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
Experience in observational studies
MSc/PhD in scientific discipline
Able to work across therapeutic areas and functions
Experience in CVMD 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.