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Associate Director, Patient Safety Scientist

Location Gaithersburg, Maryland, United States Job ID R-197348 Date posted 17/04/2024

Associate Director, Patient Safety Scientist

Location: Onsite 3 days in Gaithersburg

This isanopportunity tofurther develop yourpharmacovigilance (PV)experienceinsafety programmes,spanningthe entire life cycle of drugdevelopmentandperi-/post-submission.Our Scientists and Physiciansplay astrategicrolein developing our medicinesand thesafetyscienceof theprogramme.AstraZenecas oncology pipeline,which includesnovel combinations and modalities,provides anintellectual challenge to the safety teams, requiringabroad portfolioand scientificmanagement approach to projects.Ourteamsexperience develops as our portfoliodoes.

When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working gives us the platform we need to connect, work at pace and challenge perceptions. That’s why we work, on average, a minimum of three days per week from the office. But that doesn't mean we’re not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world.

We are looking for an experiencedAssociate Director, Patient Safety (PS) Scientistto join our Patient Safety department, workingin the Oncology Therapeutic Area. In this exciting and challenging role, you will work collaboratively with the Global Safety Physician (GSP) and other PV Scientistsand physicians,including coaching junior colleagues.  You will playa leading role in delivering the safetystrategy andrequirements for your assigned drug project(s).  Yourability to work collaborativelywill facilitatecross-functional interactionswith colleagues from across AstraZeneca and externally, including counterparts within Clinical Project Teams, Global Regulatory Affairs, and Global Commercial teams.

Asan Associate Director, PS Scientist,you willprovide leadership inaggregating,reviewing,analysingandinterpretingsafety-relateddatatogenerateinformationtosupportsafety decision-making by prescribers, patients and payers, with theultimate goalof protectingpatients.You will apply your strongPV, oncologyand scientificexperience, knowledge and skillsto leadinall aspects ofsafetydocumentation,includingauthoring and / or providingstrategic safety inputtoregulatorydocuments,e.g.,regulatory reports,health authorityresponsesandthesafety content ofmarketing authorisation applications

Essential Requirements

  • A Bachelor’s in sciences/pharmacy/nursing degreeor related fieldwith relevant experience or an advance degree with relevant experience 

  • Patient Safety and/or Clinical/Drug Developmentexperience working in or leading safety &/or scientific activities in at least 3 of the following areas:

  • Clinical drug development (Early and/or Late Phase: develop programme level safety strategy, including proactive risk identification & mitigation planning)

  • Post-Marketing Surveillance(including signal detection & evaluation)

  • MAA/BLA submissions(setting strategy; preparation and authoring of the safety related aspects of the Common Technical Document)

  • PeriodicSafetyReports(establish and lead strategy, preparation and authoring)

  • Risk Management Plans (establish and lead strategy, preparation and authoring)

  • Governance board interactionsand communicationacross a range of activities

  • Goodknowledge of PV regulations

  • Demonstrated ability to handle more than one project simultaneously, prioritizing well and recognizing key issues

  • Abilitytowork effectively in an advanced matrix structure

Preferred Requirements

  • MSc/PhD/PharmD in scientific field

  • Advanced understanding of epidemiology

Why AstraZeneca

At AstraZeneca we’re dedicated to being a Great Place to Work. Where you are empowered to push the boundaries of science and unleash your entrepreneurial spirit. There’s no better place to make a difference to medicine, patients and society. An inclusive culture that champions diversity and collaboration, and always committed to lifelong learning, growth and development. We’re on an exciting journey to pioneer the future of healthcare.

So, what's next

Are you ready to bring new ideas and fresh thinking to the table? Brilliant! We have one seat available and we hope it’s yours.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

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.

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Great culture, great work assignments, supportive management. Rotation opportunity within the company. They value inclusion and diversity.