Associate Director, Senior Patient Safety Scientist

Job Description

Description

At AstraZeneca,we work togetherto deliver innovative medicines to patientsacross global boundaries.  Wemake an impact and findsolutionsto challenges. We do this with integrity, even in the most difficult situations,because we are committed to doing the right thing.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.AstraZeneca’s oncology pipeline,which includesnovel combinations and modalities,provides anintellectual challenge to the safety teams, requiringabroad portfolioand scientificmanagement approach to projects.Ourteams’experience develops as our portfoliodoes.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. 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 ourmedicinesportfolio 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 focuson exceptional performance to drive the best and most transformative drugdevelopmentprogrammes ever.Essential RequirementsA Bachelor’s in sciences/pharmacy/nursing degreeor related fieldwith a minimum of 5 years of relevant experience or an advance degree with a minimum of 3 years of 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 activitiesGoodknowledge of PV regulationsDemonstrated ability to handle more than one project simultaneously, prioritizing well and recognizing key issuesAbilitytowork effectively in an advanced matrix structureFluent in written and verbal EnglishPreferred RequirementsMSc/PhD/PharmD in scientific disciplineAdvanced understanding of epidemiology
 
 
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