Drug Safety Specialist job Stamford Connecticut
Drug Safety Specialist job Stamford Connecticut
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Drug Safety Specialist Job



Employer Name: SpiderID: 7739693
Location: Stamford, Connecticut Date Posted: 7/11/2018
Wage: Negotiable Category: Medical/Health
Job Code: BBBH27337

Job Description:

Job Summary



  • 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 the Company's 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.


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 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.


Qualifications Required



  • 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 submit your resume for consideration. Once submitted, feel free to contact Rushi at 858-703-6733 for additional information.

Approx. Duration: 6 months

About Hired By Matrix

Hired by Matrix, Inc. founded in 1986, is a certified Woman-Owned Business Enterprise (WBE) dedicated to providing the highest quality of job opportunities to our candidates and staffing services to our clients. We are a full service staffing firm with experience recruiting and delivering for IT, Accounting & Finance, Administrative & Clerical, Clinical & Scientific, and Marketing disciplines. Our long history in the staffing industry and dedication to excellence are the key differentiators that have fueled our success for over 30 years.

Hired by Matrix offers our contract professionals competitive salaries, benefits after 60 days and a 401k option after one year.
Equal Opportunity Employer
WBENC Certified
WOSB Certified
*CEO Sharon Olzerowicz serves on the WBENC Board and is a long-standing member of the Forum Governing Group.

We work hard to match our candidates with the right career opportunities. Let us find you a #MatrixMatch so you can reach your career goals!

Connect with us on LinkedIn and see how we can impact your career!

Hired by Matrix Career Center: http://bit.ly/HbMCareers



Job Criteria:
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Position Type: Contractor
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