Associate Director, Patient Safety Scientist V&I
Location: Cambridgeshire, Gaithersburg, Maryland, Waltham, Massachusetts
Job Type: Full time
Role: Associate Director, Patient Safety Scientist
Location: Onsite with Flexibility in Gaithersburg MD, or Waltham MA, or Barcelona SP, or Cambridge UK, Warsaw PO, or Gothenburg SW
At AstraZeneca, we work together to deliver innovative medicines to patients across global boundaries. We make an impact and find solutionsto challenges. We do this with integrity, even in the most difficult situations, because we are committed to doing the right thing.
This is an opportunity to further develop your pharmacovigilance (PV) experience in safety programs,spanning the entire life cycle of drug development and peri-/post-submission.Our Scientists and Physicians play a strategic role in developing our vaccines & medicinesand the safety science of the programs.AstraZeneca’s pipeline includes novel combinations and modalities, provides an intellectual challenge to the safety teams, requiring a broad portfolio and scientific management approach to projects.Our teams’experience develops as our portfolio does.
We are looking for an Associate Director, Patient Safety (PS) Scientist to join our Global Patient Safety V&I team. Working in the Vaccines & Immune Therapies Therapeutic Area. In this exciting and challenging role, you will work collaboratively with the Global Safety Physician (GSP) and other PV Scientists and physicians. You will play a role supporting the safety strategy and requirements for your assigned project(s). Your ability to work collaboratively will facilitate cross-functional interactionswith colleagues from across AstraZeneca, including counterparts within Clinical Project Teams, Global Regulatory Affairs, and Global Commercial teams.
As an Associate Director, PS Scientist, you will be involved inaggregating, reviewing, analyzing and interpreting safety-related data to generate informationto support safety decision-making by prescribers, patients and payers, with the ultimate goalof protecting patients.You will apply your PV and scientific experience, knowledge and skills to deliverall aspects of safety documentation, includingauthoring and / or providing strategic safety input to regulatory documents, e.g.,regulatory reports, health authority responses andthe safety content ofmarketing authorization 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 adrug-developmentpipeline 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 development programs ever.
A Bachelor’s in sciences/pharmacy/nursing degree or related field with a minimum of 3 years of experience or an advanced degree with 2 plus years of relevant experience
Patient Safety and/or Clinical/Drug Development demonstrable experience working in safety &/or scientific activities in at least 3 of the following areas:
Clinical drug development (Early and/or Late Phase: develop & deliver program level safety strategy, including proactive risk identification & mitigation planning)
Post-Marketing Surveillance (including signal detection & evaluation)
MAA/BLA submissions (preparation and authoring of the safety related aspects of the Common Technical Document)
Periodic Safety Reports (deliver strategy, preparation and authoring)
Risk Management Plans (deliver strategy, preparation and authoring)
Governance board interactions and communication across a range of activities
Good knowledge of PV regulations
Demonstrated ability to handle more than one activity simultaneously, prioritizing well and recognizing key issues
Ability to work effectively in an advanced matrix structure
Fluent in written and verbal English
MSc/PhD/PharmD in scientific discipline
Understanding of epidemiology
Employer of Choice
AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics.
We offer a competitive Total Reward program including a market driven base salary, bonus and long term incentive. We also provide a generous paid time off program and a comprehensive benefits package!
AstraZeneca aligns with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.
AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.
AstraZeneca requires all US employees to be fully vaccinated for COVID-19 but will consider requests for reasonable accommodations as required by applicable law.