Drug Safety Associate

Job Description       

 

  • Attend internal, drug safety and project specific training sessions.
  • Preparation for, participation in, and follow up on audits and inspections.
  • Delegate work as appropriate to Drug Safety Assistants.
  • Assistance in development of Expedited Reporting Procedures.
  • Assistance with registration with relevant authorities for electronic reporting on behalf of sponsor.
  • Assistance with setting up and deployment of worldwide reporting as required to regulatory authorities, CECs, local ECs, and investigator sites (electronic and hard copy).
  • Submission of safety reports to investigators via ISIS (International Safety Information System).
  • Assist with measuring investigative site performance in conducting required tasks in ISIS.
  • Tracking and filing of submission cases as required.
  • Assist with unblinding of SUSARs, as required.
  • Participate in client and investigator meetings as required.

 

Qualifications

Skills:

  • Analytical and problem solving skills.
  • Able to perform database/literature searches.
  • Excellent interpersonal skills.
  • Excellent verbal / written communication skills.
  • Excellent organizational and prioritization skills.
  • Ability to work collaboratively and effectively in a team environment.
  • Client focused approach to work.
  • Experience with computer applications.

Knowledge and Experience:

  • Related experience gained in a healthcare environment is an advantage.

Education:

  • Degree in Pharmacy, Nursing, Life Science or other health-related field, or equivalent qualification/work experience.
  • Degree in any of the above with appropriate work experience.

To apply for this job please visit www.linkedin.com.

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