Manager Drug Safety Systems at Cambridge

Our client is currently seeking a MGR DRUG SAFETY SYSTEMS. The Manager Drug Safety Systems needed for client in their Drug Safety and Pharmacovigilance department. In this role you will execute and oversee all functions of Drug Safety Systems in meeting DSP departmental objectives for overall compliance as outlined by the Director of Drug Safety Systems. Requirements are minimum 6 years of experience within pharmaceutical industry required including 4 years of experience with drug safety systems and applications. BS in technical field required. Minimum 3 years of Drug Safety experience and minimum 1 years of management experience required. Advanced understanding of ICH guidelines, advanced understanding of MedDRA structure, working knowledge of Oracle databases and PLSQL programming. Advanced understanding and application of guidelines detailed in 21 CFR Part 11, including system validation requirements, advanced skills in report generation using Cognos ReportNET and Crystal and advanced understanding of Argus Safety Database skills needed. Advanced understanding of FDA regulations supporting the submission of adverse events for post-marketing and investigative drugs HUGE. In this role you will lead the design, implementation and support of applications in support of DSP objectives, including Argus Safety, PQCMS, and Reference Manager. Lead the implementation of adhoc reporting for PQCMS. Oversee programming, validation, and generation of reports for data analysis, including US periodic reports and ICH PSUR line listings. Interpret regulatory changes as they impact technology and provide technology expertise to implement regulatory changes for maintaining compliance. Plan and implement MedDRA version management and upgrades as required by the Director of Drug Safety Systems. Act as primary liaison with IT to coordinate delivery of computing infrastructure. Ensure compliance with relevant policies and procedures. Provide technology expertise for the definition and implementation of change initiatives aligned with vision and strategies. Drive resolution of complex, cross-functional issues.JO394830
Country: USA, State: Massachusetts, City: Cambridge, Company: The Judge Group.