Manager., Drug Safety Systems (50494189) Stamford, Connecticut
-Master and maintain up-to-date knowledge of the US Federal Regulations and Guidelines governing the reporting of investigational and postmarketing adverse events.
-Master and maintain 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).
-Master navigating through the ARGUS Safety Database including all details of its configuration.
-Programming, validation and generation of US periodic reports, ICH PSUR line listings and ancillary reports to support data analysis.
-Design and generation of ad-hoc reports to support queries from regulatory authorities (domestic and foreign), Purdue's Law Department, healthcare professionals and/or as requested by your immediate supervisor or the Medical Director, Drug Safety and Pharmacovigilance.
-Provide operational support for all existing and future drug safety systems (Argus Safety, SWIFT, Reference Manager).
-Master 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. Plan dictionary upgrades and versions management.
-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 4 years of experience within pharmaceutical industry required, including 4 years of experience with drug safety systems and applications
-Advanced understanding of FDA regulations supporting the submission of adverse events for post-marketing and investigative drugs
-Advanced understanding of ICH guidelines
-Working understanding of MedDRA structure
-Working knowledge of Oracle databases and SQL/PLSQL programming
-Advanced understanding and application of guidelines detailed in 21 CFR Part 11, including system validation requirements
-Working knowledge of report generation using Cognos and Crystal
-Personnel management, including recruiting, coaching and training, evaluating performance, providing feedback, development planning
-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
-Advanced understanding of safety processes
-Understanding of training concepts
-Ability to influence others
-Advanced project management skills
-Basic understanding of documentation requirements in a regulated environment
-Basic knowledge of regulatory dossier and controlled document applications