Patient Safety Assistant (parexel)

Roles and Responsibilities

Key Accountabilities:

Administrative Support:

• 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 and their tracking as applicable

• Safety database / tracking system administrative activities

• Case assignment/reconciliation

• Maintaining daily, weekly, monthly productivity data

• Line listing and tabulation generation for safety reports i.e. periodic safety reports

• Handle Ad hoc queries (as applicable)

• Support with quality assurance activities such as assisting in audits, development of templates and guidelines

• Organizing translation of study documents with external vendors

• Coordinate translation requests and manage document uploads into client or internal systems.

• Support registration with relevant authorities for electronic reporting on behalf of sponsor

• Preparing various spreadsheets per the customer/senior management requirement

• 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 submission portal 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 Project Leads as a project resource supporting internal processes and systems set-up and reporting activities

• Assist Medical Directors/Safety Physicians as needed in project-related tasks

• Arrange and attend project meetings as needed

Project Resource:

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

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

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

• Initiate, set-up and maintain Management Systems

• 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 training records, including study specific system training

• Conduct project close out in management systems at end of project

• Support other global Patient Safety Services requirements

• Collaborate with aggregate team members to perform assigned tasks and interact with other stakeholders on relevant deliverables.

• Complete assigned tasks that support the aggregate group (e.g., document archival, data collection, data reconciliation and assist with project management for the aggregate group).

• Recognizing potential issues and interacting with internal or external contacts to resolve issues.

• High level of flexibility and ability to (re)prioritize work

• Creating Job cards on Safety Tracking tool for the cases received via various sources.

• Maintaining and tracking Work in Progress (WIP)

• Maintaining daily, weekly, monthly productivity data

• Calculating and recording the daily capacity of the team

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

• Awareness 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.