Associate Director, Patient Safety Scientist

Would you like to use your drug safety or pharmacovigilance experience to make a difference to the lives of millions of patients across the world If you would please read on!

At AstraZenecawe work togetherto deliver innovative medicines to patientsacross global boundaries. Wemake an impact and findsolutionsto do this with integrity even in the most difficult situationsbecause we are committed to doing the right thing.

This isanopportunity tofurther develop yourpharmacovigilance (PV)experienceinsafety programmesspanningthe entire life cycle of drugdevelopmentandperi-/ Scientists and Physiciansplay astrategicrolein developing our medicinesand thesafetyscienceof oncology pipelinewhich includesnovel combinations and modalitiesprovides anintellectual challenge to the safety teams requiringabroad portfolioand scientificmanagement approach to 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 physiciansincluding 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 Scientistyou willprovide leadership inaggregatingreviewinganalysingandinterpretingsafety-relateddatatogenerateinformationtosupportsafety decision-making by prescribers patients and payers with theultimate goalof will apply your strongPV oncologyand scientificexperience knowledge and skillsto leadinall aspects ofsafetydocumentationincludingauthoring and / or providingstrategic safety reportshealth authorityresponsesandthesafety content ofmarketing authorisation applications.

Patient Safety sits within the Chief Medical Office where we have a crucial role to is an exciting period for us as well as for those poised to join 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 with complex disease challengeswe focuson exceptional performance to drive the best and most transformative drugdevelopmentprogrammes ever.

Essential Requirements

• A Bachelors 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 discipline

• Advanced understanding of epidemiology

Date Posted

Closing Date

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.