Detail

Salary
negotiable
Location
Gaithersburg, MD, USA
Posted by: Astra Zeneca
13 Jul
636 Views
11 Sep EXPIRED

Patient Safety Physician RIA in Gaithersburg MD

Gaithersburg, MD, USA
Job Description

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 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.

Job ID Reference
1438
Desired Skills & Experience


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
Company
  Gaithersburg, Maryland, USA
  www.astrazeneca.com
AstraZeneca is an exciting global, innovation-driven biopharmaceutical company. We’re inspired by what science can do. Driven by the desire to meet unmet patient needs in our core therapeutic areas. Bold in our thinking. Proactive in pursuing discoveries beyond imagination. At sites across the world, we bring teams together in a spirit of collaboration to turn great ideas into life-changing medicines – strengthening our product portfolio and harnessing the potential of a pipeline across all stages of the drug development process.
You’ll be part of a team that’s rolling back the frontiers of science to turn yesterday’s impossible into the normal of tomorrow. So, if you share our focus and passion, join us and make a difference to patients – and in return, we’ll help you develop way beyond what you thought possible.
  Workplace
 Gaithersburg, MD, USA