Responsibility:

• 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

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