Website Parexel Ltd
Post Name: Patient Safety Assistant
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.
