Location: Cambridge, UK or Gaithersburg, US
Competitive Salary & Benefits
At AstraZeneca, we work together to deliver innovative medicines to patients across global boundaries. We make an impact and find solutions to challenges. We do this with integrity, even in the most difficult situations, because we are committed to doing the right thing.
Our Patient Safety team offers a unique opportunity to further develop your pharmacovigilance (PV) experience in safety programmes, spanning the entire life cycle of drug development from pre-clinical and first-time-in-humans through to late stage and peri-submission. Our Scientists and Physicians play a strategic role in developing our medicines and are deeply involved in the science of the programme, leading and delivering all PV requirements.
AstraZeneca's oncology pipeline, which includes novel combinations and modalities, provides a unique intellectual challenge to the safety teams and requires a broad portfolio and scientific management approach to projects. Our teams' experience develops as our portfolio does.
We are looking for an experienced PV Scientist to join our Patient Safety department, to work in the Oncology Therapeutic Area. In this exciting and challenging role, you will work collaboratively with the Global Safety Physician (GSP) and other PV Scientists and physicians to deliver the safety requirements for your assigned drug project(s). You will collaborate with colleagues from across AstraZeneca and externally, including counterparts within Clinical Project Teams, Global Regulatory Affairs, and Global Commercial teams.
As a PV Scientist, you and your PV colleagues will be instrumental in delivering the safety strategy for the assigned drug development programme. This would include aggregating, reviewing, analysing and interpreting safety-related data to generate information to support safety decision making by prescribers, patients and payers, with the ultimate goal of protecting patients.
You will apply your strong PV and scientific experience, knowledge, and skills in all aspects of PV, including authoring and / or providing input to safety-related documents, e.g. regulatory periodic safety reports and safety content of marketing authorisation applications.
Patient Safety sits within the Chief Medical Office, where we have a crucial role to play. This is an exciting period for us, as well as for those poised to join us.
Our strategy and ability to transform our medicines portfolio means we have a drug-development pipeline that presents incredible opportunities to push the boundaries of science to deliver life-changing medicines. Faced with complex disease challenges, we focus on exceptional performance to drive the best and most transformative drug development programmes ever.
A life sciences/pharmacy/nursing degree, an MSc/PhD in a scientific discipline preferred
Demonstrable Patient Safety and/or Clinical/ Drug Development experience across a range of activities
Strong knowledge of PV regulations
Intermediate understanding of epidemiology preferred
Fluent in written and verbal English
If you are interested in this position, please apply by submitting your CV before 1st May 2019.
AstraZeneca is an equal opportunity employer. AstraZeneca will consider all qualified applicants for employment without discrimination on grounds of disability, gender or gender 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.