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Medical Director, Senior Safety Physician

AstraZeneca - Gaithersburg, MD

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Job Description

OverviewMedical Director, Senior Patient Safety Physician — you are a senior leader within Patient Safety, providing deep clinical understanding and judgement in benefit-risk assessments for AstraZeneca products. You will shape the culture of the department, coach and mentor junior Patient Safety staff, and ensure projects adhere to Good Clinical and Pharmacovigilance Practice and regulatory requirements. You should follow medical developments to incorporate emerging data and trends into the safety strategy.ResponsibilitiesProviding strategic Patient Safety input to drug development and post-marketing programsCollaborating with team members to undertake safety surveillance activities and prepare high-quality evaluation documents describing safety findingsEnsuring expert input to all elements of design and interpretation, including efficient use of tools and methodology (e.g., modelling and simulation)Providing leadership to support project discussions with governance boards, including interactions with the Patient Safety Peer Review CommitteeLeading the safety strategy for regulatory communication and overseeing higher-level documents to support submission activitiesLeading medico-scientific contributions to Risk Management Plans (RMPs) for assigned products and to Periodic Reports, including PBRERs and DSURsParticipating in advisory discussions to support other Patient Safety teams in developing their safety strategy and representing Patient Safety in cross-functional discussions with internal and external partnersMinimum RequirementsMBBS/MD or equivalent medical qualification; experience as a physician or academic clinician7+ years of proven experienceExtensive experience in Pharmacovigilance with demonstrated delivery to a high standardDetailed understanding of pharmaceutical safety, reporting and surveillance processes with strong experience in Patient Safety related to clinical trials and marketed productsExperience in designing, supervising and implementing clinical trials and interpreting trial resultsStrategic leadership of complex drug projectsUnderstanding of medico-legal aspects of pharmacovigilanceProven ability to lead cross-functional delivery teams and influence key business partnersProficiency in written and verbal communicationsPreferredPhD in a scientific field5+ years of proven experience beyond the minimumTherapeutic area expertise and commercial understandingExtensive general medical knowledge; ability to work across Therapeutic Areas and FunctionsResearch background, including peer-reviewed publicationsDate Posted03-Sept-2025Closing Date29-Nov-2025EEO StatementOur mission is to build an inclusive environment where equal employment opportunities are available to all applicants and employees. We welcome and consider applications from all qualified candidates, regardless of protected characteristics. If you have a disability or special need that requires accommodation, please complete the corresponding section in the application form.Seniority levelDirectorEmployment typeFull-timeJob functionHealth Care ProviderIndustriesPharmaceutical ManufacturingReferrals increase your chances of interviewing at AstraZeneca. #J-18808-Ljbffr

Created: 2025-10-06

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