Website AstraZeneca India ltd
Post Name: Local Case Intake Advisor – Global Business Services
Career Level: C
Introduction to role:
Are you passionate about patient safety and compliance? As a Local Case Intake Advisor, you will manage the intake, processing, and reporting of individual case safety reports (ICSRs) at the local level. You will support specific local Marketing Companies to ensure compliance with AstraZeneca (AZ) and relevant national regulatory requirements, serving as the primary liaison between those Marketing Companies and GBS-PS. This role requires fluency in English and involves working under the guidance of Case Intake Team Managers to deliver routine activities independently, resolve moderate scope problems, and conduct activities consistent with things we value and compliance standards.
Accountabilities:
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: Indonesian 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
