Drug Safety Assistant

• Support development and maintenance of Central Files Maintenance Plan (CFMP)

• Perform filing and archiving such as filing documentation in the departmental working files and submitting information to central files

• Prepare draft project plan including all sub plans per templates (Communication plan, Risk Management plan, MSP, WSOP listing, Quality plan, etc.)

• Initiate, set-up and maintain Management Systems on a regular basis (GXDB, CTMS, PMED, other systems as required).

• Prepare project related data for analysis such as TIME/task code analysis, operational metrics and compliance reports

• Arrange project related training and maintain project specific trainings overview and records, including study specific system training members (e.g. ARGUS, ISIS, PMED)

• Conduct project close out in management systems at end of project (GXDB, ARGUS, PMED, and other systems as required.

Skills:

• Analytical and problem solving skills

• Able to perform basic searches via the internet or other comparable data repositories

• Good interpersonal skills

• Good verbal / written communication skills

• Good organizational and prioritization skills

• Ability to work collaboratively and effectively in a team environment Client focused approach to work

• Knowledge of medical terminology

• 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

• Associates/diploma degree in any of the above with appropriate work experience