Drug Safety Systems Analyst

Katalyst HealthCares & Life Sciences - Cambridge, MA (30+ days ago)


This position is an experienced analyst on the Global Drug Safety (GDS) Information Management team.

Responsibilities:

  • Provide direct technical /data management support to ensure information entered and retrieved from the Global Drug Safety systems is consistent, accurate and complete.
  • Provide technical expert in GDS for data management, reports and queries.
  • Ensure GDS data outputs are complete and accurate.
  • Drive the standardization of GDS information management (including implementation of self-service tools) to ensure consistency across solutions.
  • Foster collaboration with stakeholders to ensure accurate interpretation of the business need.

Support Information Management tasks/projects requiring technical expertise with respect to Global Drug Safety.

  • Support cross-functional information management initiatives.

Requirements:

  • Experience with Argus Safety, SQL programming/querying, custom report design/development preferably using a structured tool (e.g. Cognos, Business Objects).
  • Excellent analytical, decision-making, organizational, managerial, interpersonal and communication skills.
  • In-depth knowledge of key aspects of Global Drug Safety processes.
  • Ability to interpret and apply regulatory requirements.
  • Technical understanding of Pharmacovigilance systems and software development methodologies.
  • Knowledge of systems integration and data interchange standards.
  • Proficient in the use of one or more of the leading Information Management Systems or programming environments.
  • Experience with analysis and support of continuous process improvement initiatives.
  • BA/BS and 5 years’ experience or equivalent.
  • 3+ years Systems and/or Information Management experience in the Pharmaceutical, Device or Biotech industries or equivalent (Sponsor, CRO or combination).
  • 1+ years of project leadership and global and/or cross-functional collaboration experience.

Job Type: Contract

Experience:

  • Argus Safety: 4 years (Required)
  • Global Drug Safety systems: 4 years (Required)
  • SQL programming/querying: 3 years (Required)

Education:

  • Bachelor's (Required)