Drug Safety Assistant

1 month ago


Beijing, China Parexel Full time

When our values align, there's no limit to what we can achieve.
 

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



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