Safety Scientist

1 day left

Employer
AstraZeneca Pharmaceuticals LP
Location
Gaithersburg, MD
Posted
May 02, 2021
Closes
May 09, 2021
Function
Other
Hours
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.