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- Full Time
Safety Scientist sought by AstraZeneca Pharmaceuticals LP in Gaithersburg, MD (F/T) to provide inputs to the dvlpmt of strategic & tactical plans for techn'l regulatory & safety knowl. to stakeholders. Req'ts: Master's deg. or foreign equiv in Regulatory Affairs, Pharmacy or rel + 3 yrs of exp in position offrd or rel w/in the patient safety or pharmaceutical industry. Must have 3 yrs of exp in the patient safety or pharmaceutical industry in each of the following: Waterfall & Agile methodology for S/ware Dvlpmt Life Cycle; FDA 21 CFR part 11(Electronic Records & E-signatures), 210, 211, Annex 11 regulations, global qlty & safety reporting regulatory expectations incl as GxP Validation, ICH E2B R2/R3 (HL7) stndrds, & Individual case safety reporting; Delivering validation strategies for GxP systems incl EDMS, EQMS & Pharmacovigilance systems incl ARISg, Argus Safety or bespoke PV system; Dsgn, deployment of solutions in support of safety in the context of Pharmacovigilance systems incl ARISg, Argus Safety or bespoke PV system; Perform comp. system validation, testing & techn'l writing incl User reqmts, Functional reqmts, Risk assessments, Part 11 & Annex 11 reqmt assessments, Procedural controls, & SOP Planning forms; & Test Protocols, Installation qualification, Operational Qualification, Performance Qualification, Configuration reports, Traceability Matrix & Summary reports for various GxP systems w/ strict adherence to GAMP regulations. Apply: http://www. astrazenecacareers.com. "Search jobs," enter "R104210" as the "Keyword," & click "Search." No calls. EOE.