Drug Safety Coordinator

1 month ago

Beijing, Beijing, China Parexel Full time
Job Summary

Parexel is seeking a highly skilled Drug Safety Assistant to join our team. As a key member of our safety team, you will be responsible for ensuring the integrity and quality of our safety data.

Responsibilities
  • Triage and Data Entry: Triage incoming reports for completeness, legibility, and validity, and perform initial data entry of case reports into our safety database/tracking system.
  • Follow-up Requests: Conduct written and telephone follow-up requests as necessary.
  • Safety Database Administration: Perform administrative activities related to our safety database/tracking system.
  • Case Reconciliation: Reconcile case reports to ensure accuracy and completeness.
  • Reporting and Analysis: Generate line listings and tabulations for safety reports, including periodic safety reports, and perform ad hoc queries as needed.
  • Quality Assurance: Assist in audits, develop templates and guidelines, and perform quality assurance activities to ensure compliance with regulatory requirements.
  • Translation and Registration: Organize translation of study documents with external vendors and support registration with relevant authorities for electronic reporting on behalf of sponsors.
  • Submission and Tracking: Support the submission of safety reports to investigators via ISIS and track and file submission cases as required.
  • Metrics and Performance: Collect and review metrics for measuring reporting compliance and project-specific operational performance, and measure investigative site performance in conducting required tasks.
  • Unblinding and Support: Unblind SUSARs as required and provide internal support to SSPMs as a project resource, supporting internal processes and systems set-up and reporting activities.
  • Central Files Maintenance: Support the development and maintenance of Central Files Maintenance Plans (CFMPs) and perform filing and archiving activities.
  • Project Planning: Prepare draft project plans, including communication plans, risk management plans, and quality plans, and initiate, set-up, and maintain management systems on a regular basis.
  • Data Analysis and Training: Prepare project-related data for analysis, arrange project-related training, and maintain project-specific trainings overview and records.
  • Close-out and Requirements: Conduct project close-out in management systems at the end of projects and support the collection and organization of global Safety Services requirements.
  • Country-Specific Requirements: Maintain updated country-specific requirements in PAREXEL's Safety Services repository and communicate regulatory updates to project teams as required.
  • Named Safety Contacts: Maintain an updated network list of Named Safety Contacts/LQPPVs.
  • Standalone Projects: Work directly with relevant stakeholders on standalone GPIO projects and assist Medical Directors/Safety Physicians as needed in project-related tasks.
  • Meetings and Support: Arrange and attend project meetings as needed.
Requirements
  • Education: Degree in Pharmacy, Nursing, Life Science, or other health-related field, or equivalent qualification/work experience.
  • Experience: Related experience gained in a healthcare environment is an advantage.
  • Skills: Analytical and problem-solving skills, ability to perform basic searches, good interpersonal and 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, and experience with computer applications.

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