Drug Safety System Analyst (50492144) Stamford, Connecticut
Major objective of the position is the generation of production deliverables. Deliverables includes and are not limited to:
-Adhoc queries of Argus Safety using Cognos.
-Implementations of new and versioned DSP systems
-Administration of all DSP systems
-Standard operating procedures and Working practice documents
-Working knowledge of the US Federal Regulations and Guidelines governing the reporting of investigational and postmarketing adverse events.
-Basic knowledge of the ICH regulations and guidelines governing the global reporting of adverse events on investigational and/or marketed products (particularly ICH E2A, E2C and E2B).
-Working knowledge of navigating through the ARGUS Safety Database including all details of its configuration.
- Basic knowledge of US periodic reports, ICH PSUR line listings and ancillary reports to support data analysis.
-Provide operational support for all existing and future drug safety systems (Argus Safety, SWIFT, bibliographic software).
-Basic knowledge of the MedDRA principles and hierarchy and the regulations and guidelines to assist in the conversion of legacy data and the implementation of MedDRA into the Argus Safety application.
-Assist in management and administration of international adverse event database: Quality control monitoring, administration of user accounts, dictionary maintenance, configuration management, providing user support (with referral to IT when necessary).
-Act as a DSP Systems liaison with the IT Department.
-Interact with internal and external groups on drug safety operations issues, when necessary.
-Assist in other departmental tasks, as assigned by your immediate supervisor or the Medical Director, Drug Safety and Pharmacovigilance, to ensure Purdue's compliance with all FDA and ICH regulations and guidelines governing the reporting of adverse events and product complaints.
Minimum BS in technical field required.
Required Experience & Technical Requirements
-Minimum 3 years of experience within pharmaceutical industry required, including 3 years of experience with drug safety systems and applications
-Minimum 3 years of Drug Safety experience
-Working understanding of FDA regulations supporting the submission of adverse events for post-marketing and investigative drugs
-Working understanding of ICH guidelines
-Working understanding of MedDRA structure
-Working knowledge of Oracle databases and SQL/PLSQL programming
-Working understanding and application of guidelines detailed in 21 CFR Part 11, including system validation requirements
-Working knowledge of report generation using Cognos and Crystal
-Working understanding of Argus Safety Database
-Proficiency with basic MS Office applications
-Working knowledge of scientific terms and medical terminology
-Written and verbal communication skills; interpersonal skills
-Time mgmt and ability to prioritize workload (self, others)
-Quality orientation: attention to detail, accuracy
-Basic understanding of safety processes
-Basic understanding of documentation requirements in a regulated environment
-Basic knowledge of controlled document and regulatory dossier applications, PC database
-Working understanding of Purdue processes, org, reqmts