Associate Director, Senior Patient Safety Scientist
Introduction:
TheAssociate Director, Senior Patient Safety Scientistrole leads the review of safety data and related documents for potential safety issues in collaboration with the Global Safety Physician (GSP) and (Associate) PV Scientist. He/she authors and leads PV input to safety documents and regulatory reports.Associate Director, Senior Patient Safety Scientistleads meetings and presents safety data and analyses.
Main Responsibilities:
Leads and/or conducts proactive pharmacovigilance and risk management planning formore complexproducts, including preparation of the safety aspects ofGlobal Risk Management PlansandRisk Evaluation and Mitigation Strategies (REMS)in partnership with theGSP and others as appropriate.
LeadsPSactivitiesofcross-functional project teams for developmental compounds and/or marketed products.
Leads and providessafetyexpertisetoInvestigatorBrochures,Protocols,InformedConsentsandClinicalStudyReports.
Has the ability toperform duties as aSafety Strategy and ManagementTeam (SSaMT)Leader for larger or more complex projects.
Presents complex issues to Safety Information Review Committee (SIRC) and takes the lead role in data evaluation and discussion of the results with the SIRC Chair, GSP and other key stakeholders.
Leads the collaboration with GSP and Clinical representatives and authors theReference Safety Information (RSI)for multiple or complex development products.
Authors/provides strategic input or oversight for multiple or complex periodic regulatory documents (PBRERs, PSURs, DSURs) according to the agreed process and timelines.
Authors/provides strategic leadership to regulatory submissions for new products,formulationsor indications (NDA/BLA, MAA), in partnership with the GSP and other functional experts.
Participates in negotiations and providesexpertisetothe PScomponentof contracts/agreements with third parties to ensure quality and integrity of agreements.
Trains andmentorsjunior members of the team, e.g. in approved PV processes, analytic methodologies, etc.
Requirements – Education and Experience
A life sciences/pharmacy/nursing degree,anddemonstratedPatient Safety and/or Clinical/ Drug Development experience
Fluent in written and verbal English
Advanced knowledge of PV regulations
MD/MSc/PhD in scientific discipline, preferred
Intermediate understanding of epidemiology, preferred
Date Posted
06-mar-2026Closing Date
22-mar-2026AstraZeneca 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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