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Drug Safety Specialist

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 services team, you will be responsible for ensuring the highest level of quality and compliance in our safety reporting processes.

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 follow-up requests via written and telephone communication.
  • Safety Database Administration: Perform administrative activities related to our safety database/tracking system.
  • Case Reconciliation: Reconcile case reports and ensure accuracy.
  • Reporting and Analysis: Generate line listings and tabulations for safety reports, including periodic safety reports, and perform ad hoc queries.
  • Quality Assurance: Assist in audits, develop templates and guidelines, and perform quality assurance activities.
  • Translation and Regulatory Support: Organize translation of study documents with external vendors and support registration with relevant authorities for electronic reporting on behalf of the sponsor.
  • Project Support: Support setting up and deployment of worldwide reporting as required to regulatory authorities, CECs, local ECs, and investigator sites.
  • Submission and Tracking: Support 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.
  • Central Files Maintenance: Support development and maintenance of Central Files Maintenance Plan (CFMP) and perform filing and archiving activities.
  • Project Planning: Prepare draft project plans, including communication plans, risk management plans, and quality plans.
  • System Management: Initiate, set up, and maintain management systems on a regular basis.
  • Data Analysis and Training: Prepare project-related data for analysis and arrange project-related training.
  • Project Close-out: Conduct project close-out in management systems at the end of the project.
  • Global Safety Services: Support collection and organization of global Safety Services requirements and maintain updated network lists of Named Safety Contacts/LQPPV.
  • Standalone Projects: Work directly with relevant stakeholders on standalone GPIO projects and assist Medical Directors/Safety Physicians 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, and ability to work collaboratively and effectively in a team environment.