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Gaithersburg, Maryland, United States
Job reference: R-048343
Posted date: May. 10, 2019

Location: 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 Senior 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 and play a leading role in delivering the safety requirements for your assigned drug project(s).  Your ability to work collaboratively will facilitate cross-functional interactions with colleagues from across AstraZeneca and externally, including counterparts within Clinical Project Teams, Global Regulatory Affairs, and Global Commercial teams.

As a Senior PV Scientist, you will be instrumental in leading 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 to lead 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.

Essential Requirements

  • A life sciences/pharmacy/nursing degree; an MS/PhD in scientific discipline preferred
  • Demonstrable Patient Safety and/or Clinical/ Drug Development experience across a range of activities
  • Strong working knowledge of PV regulations
  • Good understanding of epidemiology preferred.
  • Fluent in written and verbal English

Demonstrable experience working in or leading safety &/or scientific activities in at least 3 of the following areas:

  • Clinical drug development (Early and/or Late Phase)
  • Post-Marketing Surveillance
  • MAA/BLA submissions
  • Periodic Reports
  • Risk Management Plans (authoring/working ‘from scratch’)
  • Governance board interactions

If you are interested in this position please apply by submitting your resume. Thank you.

Senior PV Scientist or PV Scientist
Clinical Development

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