Computer & Information Systems Manager
Computer & Information Systems Manager for GForce Life Sciences (Waltham, MA).
Review project plans & provide analysis of changes & enhancements required by business.
Requires:
Bachelor (or foreign equivalent) in computer engineering, computer science, or related 5 years experience as Computer Systems Analyst, Associate or related. 5 years experience is required & must include: Utilizing Oracle Argus Safety application & database to develop Drug Safety Pharmacovigilance reports in support of internal/external audits, quality assurance & safety and aggregate reporting analysis. Utilizing Oracle Argus Interchange to transmit ICH ICSR elect trans and exchange drug safety info w regulators & partners worldwide. Ensure Oracle Argus Safety Pharmacovigilance platform reporting is in compl with FDA, EMEA & other regulatory authorities regulations & guidelines (including CFR Title 21 seconds 310.305, 312.32, 314.80). Oracle SQL & PL-SQL programming, & Relational Database Management System (RDBMS & DBMS) reporting. Utilize Software Engineering/SDLC to perform end to end validation for development activities & prepare qualifications documents(1Q/0Q/PQ) in support of validation activities.