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Manager, Drug Safety Systems Admin

Company: Fast Switch, Ltd. - Right Talent. Right Time.
Location: Stamford
Posted on: February 24, 2021

Job Description:

Our Client in Stamford, Connecticut is seeking a Manager, Drug Safety Systems Administrator for a contract roleCan work remotely ?NO CORP-TO-CORP SUBMISSIONS ACCEPTED FOR THIS POSITION.--Applicants must be able to work directly for Fast Switch as a W2 Employee (US Citizens and all other parties authorized to work in the US without sponsorship are encouraged to apply). Under the leadership of the Associate Director, Drug Safety Systems, the Manager, Drug Safety Systems Administrator 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 the Client's IT function, 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.Primary Responsibilities* 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--compliance with all FDA and ICH regulations and guidelines governing the reporting of adverse events and product complaints.* Education and Experience Requirements* MS in technical field preferred; BS in technical field required; concentration in Computer Science or Information technology fields is preferred.* Minimum 6 years of experience within pharmaceutical industry required, including 4 years of experience with drug safety systems and applications.* Minimum 1 year of management experience preferred.* Necessary Knowledge, Skills, and Abilities* Very good understanding of Argus Safety.* 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.* Excellent written and verbal communication skills; interpersonal skills.* Organization and Analytical skills.* Expert time management skills, with the ability to prioritize workload (self, others).* Quality orientation:--attention to detail, accuracy.* Project management and multitasking skills.* Understanding the importance of documentation requirements in a regulated environment.* MUST: Argus Safety AND Cognos. Maintenance coding.

Keywords: Fast Switch, Ltd. - Right Talent. Right Time., Stamford , Manager, Drug Safety Systems Admin, Executive , Stamford, Connecticut

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