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Safety Associate
Ref No.: 18-08653
Location: Cambridge, Massachusetts
Position Type:Prof
Start Date / End Date: 05/20/2018 to 05/19/2019
Job Description:
 
TRUE JOB TITLE: 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.
 
Requirements:
 
  • 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.
 
Skills Required:
 
  • 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.
Apply on-line for immediate consideration, please send your updated resume and contact info via
Contact: Asha Krishna
Email: asha@sunrisesys.com | 732-395-4591