Drug Safety Specialist

5 days 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 timely and accurate reporting of adverse events and other safety-related information.

Responsibilities
  • Triage and Data Entry: Triage incoming reports for completeness, legibility, and validity, and perform initial data entry of case reports into safety databases and tracking systems.
  • Follow-up and Administrative Activities: Conduct follow-up requests, including written and telephone communications, and perform safety database and tracking system administrative activities.
  • Case Reconciliation and Reporting: Reconcile case reports, generate line listings and tabulations for safety reports, and perform ad hoc queries.
  • Quality Assurance and Regulatory Compliance: Assist in audits, develop templates and guidelines, and ensure compliance with regulatory requirements.
  • Translation and Submission: Organize translation of study documents with external vendors, support registration with relevant authorities, and submit safety reports to investigators and regulatory authorities.
  • Metrics and Performance Monitoring: Collect and review metrics for measuring reporting compliance and project-specific operational performance, and measure investigative site performance.
  • Unblinding and Central Files Maintenance: Unblind SUSARs as required and maintain central files, including filing and archiving documentation.
  • Project Support and Development: Provide internal support to SSPMs, assist in the development and maintenance of Central Files Maintenance Plans, and prepare project-related data for analysis.
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 in a team environment.
What We Offer

Parexel offers a dynamic and challenging work environment, with opportunities for professional growth and development. We are committed to providing our employees with the tools and resources they need to succeed.



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