Location: 
Waltham
Employment Type: 
Contract
Job ID: 
133745
Description: 

6 Month contract 15 hours/week

Responsibilities:

  • Develop standard and ad hoc reports from the safety database
  • Create queries and generate custom reports
  • Produce reports from Arisg and BO
  • Create complex SQL database searches from scratch
  • Ensure that search algorithms are clearly and consistently documented
  • Ensure that quality checks are completed for highest quality of the output
  • Ensures that all programming is validated and of the highest quality to meet all department SOPs and regulatory requirements.
  • Collaborate with Management in the establishment of productivity /quality metrics and independently track and report data in compliance with Good Pharmacovigilance Practices (GVP)
  • Perform safety systems administrator activities, including the maintaining code lists and database libraries, user roles and responsibilities, workflow updates, distribution matrixes and automated submissions, narrative templates, and data entry validations
  • Provide business analyst support through the understanding existing business processes in order to identify business solutions and requirements for new functionalities, performing impact analysis on systems and processes, and potential ongoing projects, along with their implementation or reconfiguration
  • Conduct routine and ad hoc data extraction (i.e. Summary of Like Events, Ad hoc Line Listings, DSURs, 6-monthly listings)

 

  • BS in Computer Science (or related experience)
  • Strong and extensive Oracle SQL and PL/SQL skills
  • Oracle ARISg experience is a must
  • 5+ years DBA & Programming experience is required
  • Previous pharmaceutical safety experience is required
  • Experience with MedDRA coding dictionary is required
  • Understanding of signal detection methodologies preferred
  • A minimum of 5 years prior experience supporting pharmaceutical organization is required
  • Detail-oriented and persistent with excellent organizational skills
  • Proficient with Safety databases, Microsoft Word, Excel, Access, SharePoint
  • Knowledge of other software and programming languages and tools is preferred (SAS, VB, VBScript, .NET, MS Access, Oracle, MS SQL Server, JReview, Business Objects, Cognos, etc.)
  • Familiarity with medical terminology
  • Strong verbal and written communication and interpersonal skills
  • Ability to organize workflow activities and multi-task, be performance driven and possess good decision making skills.
  • Prior experience with providing operational support in a regulated environment and/or knowledge of US/Global regulations governing adverse event reporting is desired

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