Job Title: Associate Director Senior Patient Safety Scientist V&ILocation: Onsite with flexibility in Gaithersburg MD, Waltham MA, Cambridge UK, Gothenburg SW, Warsaw PO or Barcelona SPAt 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.This is an opportunity to further develop your pharmacovigilance (PV) experience in safety programs globally. Your involvement spans the entire life cycle of drug development and peri-/post-submission.Our Scientists and Physicians play a strategic role in developing our medicines and the safety science of the program. AstraZeneca's drug development pipeline includes novel combinations and modalities, and 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, Senior Patient Safety (PS) Scientist to join our Patient Safety department, working in the Vaccines & Immune Therapies 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 drug project(s). Your ability to work collaboratively will facilitate cross-functional interactions with colleagues from across AstraZeneca, including counterparts within Clinical Project Teams, Global Regulatory Affairs, and Global Commercial teams. 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 progressive drug development programs ever!Minimum Education, Skills and Experience RequiredA Bachelor's in sciences/pharmacy/nursing degree or related field3+ years of proven experience (industry experience is preferred)Patient Safety and/or Clinical/Drug Development proven 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 activitiesGood knowledge of PV regulationsDemonstrated ability to handle more than one activity simultaneously, prioritizing well and recognizing key issuesAbility to work effectively in an advanced matrix structureProficient in written and verbal EnglishPreferred Education, Skills and ExperienceMSc/PhD/PharmD in scientific field3+ years of relevant industry experienceUnderstanding of epidemiologyAstraZeneca is an Employer of Choice because...If that's not got your attention, now read this...We offer an industry wide generous Total Reward program including a market leading base salary + cash bonus + long term incentive = shareholder status. We also provide a generous paid time off program and a broad comprehensive benefits package to include medical, dental, vision care, 401K among other diversity friendly offerings. AstraZeneca aligns with all applicable laws and regulations on non-discrimination in employment, as well as work authorization and employment eligibility verification requirements.
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