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
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
Support collection and organization of global Safety Services requirements
Data entry and maintenance of country specific requirements in PAREXEL’s Safety Services repository
Receipt and triage of requests for updates to country requirements
Communicate country-specific regulatory updates to project teams as required
Maintain updated network list of Named Safety Contacts/LQPPV
Work directly with relevant stakeholders on standalone GPIO projects
Assist Medical Directors/Safety Physicians as needed in project-related tasks
Arrange and attend project meetings as needed
Qualifications
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
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
