Intern

Major accountabilities:

• Pharmacovigilance Operations Support
  • Assist in the intake and tracking of adverse event (AE) reports from various sources (e.g., PSPs, HCPs, internal stakeholders)
  • Support case documentation and ensure completeness of required safety data before submission
  • Perform data entry and reconciliation in safety tracking tools or local logs
  • Assist in follow-up activities for missing information under supervision

Compliance and Documentation

• Support maintenance of PV documentation, including local SOPs, working instructions, and training records
• Participate in document review and formatting for audit readiness

Safety Reporting and Monitoring

• • Assist in tracking submission timelines for Individual Case Safety Reports (ICSRs)
  • Support preparation of periodic reports, metrics, or dashboards as required

Cross-functional Collaboration

• Coordinate with internal stakeholders (e.g., Medical Affairs, PSP teams, Quality) to collect safety information
• Support communication with external service providers (ESPs) if required
• Participate in internal meetings and contribute to meeting minutes or action tracking

Key performance indicators:

• Timely and accurate support of AE processing activities
• Compliance with internal procedures and documentation standards
• Quality and completeness of assigned tasks
• Contribution to audit readiness and team deliverables

Minimum Requirements:
Work Experience:

• NA.

Skills:

• Strong attention to detail and data accuracy
• Good organizational and documentation skills
• Effective communication (written and verbal)
• Ability to handle confidential information with integrity
• Proficiency in Microsoft Office (Excel, PowerPoint, Word), Copilot
• Fluent in English; Chinese is a plus

Languages :

• English.