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Principal Analyst, Global Drug Safety (GDS) Information Management
Ref No.: 18-13997
Location: Cambridge, Massachusetts
Job Title: Principal Analyst, Global Drug Safety (GDS) Information Management
Duration: 12+ Months with possible extension
Location: Cambridge, MA 02142
Details: Principal Analyst, Global Drug Safety (GDS) Information Management: This position is an experienced analyst on the Global Drug Safety (GDS) Information Management team. The Principal Analyst provides direct technical /data management support to ensure information entered and retrieved from the Global Drug Safety systems is consistent, accurate and complete. The GDS Principal Analyst is a 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.
  • 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. Current with industry developments, trends and opportunities.
Education and Experience Requirements:
  • 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.
Gaurav Vatsa
13454 Sunrise Valley Drive, Suite 120, Herndon, VA 20171
Direct: 703-889-6667 | Fax: 703-889-6500  |