Local Case Intake Advisor - Global Business Services

Job Description

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