LSO responsibilities include:
- Compliance of Local Pharmacovigilance Operations with Company SOPs and Work Instructions
- Receipt and Oversight of Processing of Adverse Events Reported
- Case Reconciliation of Reported Cases with Internal and External Partners
- Review of Local Labeling Changes
- Provision of Appropriate Safety-Related Information in Response to External Queries
- Review of Local SDEAs
- Training for Key Personnel Including External Partners
- Manage the Preparation and Implementation of Local Risk Mitigation Measures
- Optimization of Local Processes Managing Adverse Event Reporting
- Support the Submission of Reports to Local Authorities
- Inspection Readiness and Oversight of Deviations/CAPA’s