Parexel is an equal opportunity employer.  Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, etc.

The Patient Safety Assistant will provide technical, process-related and administrative support to Patient Safety management, Patient Safety Project Leads and medical monitoring activities, regulatory information collection and organization, regulatory reporting, and medical project management activities.

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.