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Local Safety Officer (LSO) Services

Experienced Local Safety Officers to Support Regional Pharmacovigilance Activities and Engage with Health Authorities

ClinChoice’s LSOs will be responsible for regulatory compliance of all the pharmacovigilance activities in their assigned locations. In addition to being the client’s local representative for pharmacovigilance, the officers will enhance the quality of the regional drug safety operations and liaise with regulatory affairs to meet compliance requirements.

Our LSOs remain abreast with the latest EU and local safety regulations with the support of our in-house PV intelligence team.

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