Local Case Intake Advisor - Global Business Services

• Support provision of pharmacovigilance activities including local processes, procedures, and systems for collection, reporting, and tracking of Adverse Events (AEs).
• Review, assess, and process safety data from various sources, distributing reports to internal and external third parties.
• Identify Product Quality Complaint (PQC) and Product Security complaints, collecting necessary information for AE complaint reporting.
• Provide prompt support for regulatory authority queries related to the Patient Safety function.
• Implement Corrective and Preventative Actions in the event of local non-compliance.
• Ensure reconciliations for the accuracy of pharmacovigilance data transferred and received.
• Periodically screen regulatory authority databases for adverse events.
• Perform literature search and related activities for MC product portfolio if required.
• Undertake manual follow-up where required, disseminating clear and accurate information based on approved call scripts.
• Maintain filing and archiving practices of patient safety documents.
• Actively contribute to maintaining Good Pharmacovigilance Practice and being audit and inspection ready.
• Support external service providers to meet company and local regulatory PV requirements.
• Assist the local PS team in audits or regulatory authority inspections.
• Complete all required patient safety trainings and obtain access to relevant systems.
• Maintain current knowledge of relevant country regulatory authority regulations, global and local procedural documents, marketed status of products, and conditions relating to product safety.

Essential Skills/Experience

• Degree Qualified - Pharmacy/ Medical/ Science
• Language skill - Thai and Vietnamese
• Pharmacovigilance knowledge excellence
• Good Pharmacovigilance Practice
• Knowledge of health authority regulations
• Cross-functional collaborative approach
• Effective and lateral thinking
• Problem solving
• Vendor management
• Excellent attention to detail
• Excellent written and verbal communication skills

Desirable Skills/Experience

• Influencing and Conflict Resolution skills
• Medical knowledge in company Therapeutic Areas
• Project management
• Successful participation in above-market projects
• Audit & Inspection experience