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Principal Analyst, Global Drug Safety Information Management in Cambridge, MA at Apex Life Sciences

Date Posted: 11/19/2018

Job Snapshot

  • Employee Type:
  • Location:
    Cambridge, MA
  • Job Type:
  • Experience:
    Not Specified
  • Date Posted:
  • Job ID:

Job Description

Principal Analyst, Global Drug Safety Information Management

1-year contract

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.


  • 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.

EEO Employer

Apex is an Equal Employment Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at 844-463-6178.