Drug Safety Consultant
Previous Job
Drug Safety Consultant
Ref No.: 18-00096
Location: Stamford, Connecticut
Howard Systems seeks a Drug Safety Consultant for a contract in Stamford, Ct.

Assignment Description: the Drug Safety Systems Consultant is responsible for providing systems support for Drug Safety and Pharmacovigilance activities, including technical and programming support, managing small to medium technical projects, and interacting with our clients IT function, EU Drug Safety Systems, and safety database vendors on technical matters. This role will support the Drug Safety team on safety systems related functions, including troubleshooting issues and liaising with appropriate partners to facilitate issue tracking and resolution.
  • Summary of Work:
  • Responsible for the management and administration of international adverse event database:  administration of user accounts, dictionary maintenance, configuration management, E2B reporting, providing user support (with referral to IT when necessary) etc.
    ·Program, validate and generate periodic reports, to include ICH PSUR line listings and ancillary reports to support data analysis.
    ·Design and generate ad-hoc reports to support queries from regulatory authorities (domestic and foreign), healthcare professionals, other client departments such as Law, Medical affairs, etc.
    ·Collaborate on the design, implementation, upgrade, validation, and support of applications, including Argus Safety, Empirica Signal, IBM Cognos, Axway, SWIFT, and Drug Safety Triager.
    ·Train and provide knowledge transfer to other DSS members and consultants.
    ·Analyze, design, program, and implement solutions to address technical issues and/or requirements.
    ·Interpret regulatory changes as they impact technology and provide technology expertise to implement regulatory changes for maintaining compliance.
    ·Plan and implement MedDRA and WHO-DD version management and upgrades as required.
    ·Liaise with IT and EU Drug Safety Systems to coordinate delivery of computing infrastructure.
    ·Ensure compliance with relevant policies and procedures.
    ·Adhere to standard operating procedures and ensure appropriate documentation to back up all compliance related activities are upheld.
    ·Master and maintain up-to-date knowledge of the US Federal Regulations and Guidelines governing the reporting of investigational and post marketing 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).
    ·Assist in other departmental tasks, as assigned by your immediate supervisor, to ensure our clients compliance with all FDA and ICH regulations and guidelines governing the reporting of adverse events and product complaints.

    Necessary Knowledge, Skills, and Abilities
    ·Exceptional understanding of Drug Safety Database such as Argus Safety, ARISg etc.
    ·Solid working knowledge of Oracle databases and PLSQL programming.
    ·Excellent skills in report generation using Cognos. Skills on OBIEE will be a plus.
    ·Exceptional understanding of FDA regulations supporting the submission of adverse events for post-marketing and investigative drugs.
    ·Exceptional understanding of ICH guidelines and MedDRA structure.
    ·Solid understanding and application of guidelines detailed in 21 CFR Part 11, including system validation requirements.
    ·Knowledge of Safety Signal detection and Data Mining is a preferred.
    Proficiency with basic MS Office applications. Advanced Microsoft excel skills is preferred 
    Please, let me know what time I can call you tomorrow.