Key Accountabilities:

Supporting Activities

• Triage of incoming reports for completeness, legibility and validity
• Initial data entry of case reports into safety database / tracking system
• Follow-up requests i.e. written, telephone
• Safety database / tracking system administrative activities
• Case reconciliation
• Line listing and tabulation generation for safety reports, i.e. periodic safety reports
• Ad hoc queries
• Quality Assurance activities such as assisting in audits, development of templates and guidelines
• Organizing translation of study documents with external vendors
• Support registration with relevant authorities for electronic reporting on behalf of sponsor
• Support setting up and deployment of worldwide reporting as required to regulatory authorities, CECs, local ECs, and investigator sites (electronic and hard copy)
• Support submission of safety reports to investigators via ISIS
• Tracking and filing of submission cases as required
• Collection and review of metrics for measuring reporting compliance and project specific operational performance
• Measuring investigative site performance in conducting required tasks
• Unblinding of SUSARs, as required and as appropriate
• Provide internal support to SSPMs as a project resource supporting internal processes and systems set-up and reporting activities

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