Scitus has a dependable team of experts who efficiently work through the entire scope of Pharmacovigilance activities. We offer a high level of expertise to plan services that fit the needs of both your product and study, while meeting the highest standards of applicable regulations.
Pharmacovigilance Service
Our Capabilities
- Medical Information Call Centre Services
- Drug safety database support
- Individual Case Safety Report (ICSR) management: Processing, Quality review, Medical review and Global reporting
- Literature screening
- Risk Management Plan (RMP) writing
- Aggregate report writing - PSUR, PBRER, PADER and ACOs
- Preparation of Pharmacovigilance System Master File (PSMF)
- Qualified Person Responsible for Pharmacovigilance (QPPV), Pharmacovigilance Officer in Charge (PvOI) and Local Responsible Person for Pharmacovigilance (LRPV)
- Extended EudraVigilance Medicinal Product Dictionary (XEVMPD)/Identification of Medicinal Products (IDMP) entries and maintenance
- Signal Detection and Evaluation
- Pharmacovigilance Training and Consultancy
- Recommendations for Pharmacovigilance department designing, development and improvement
- Pharmacovigilance Quality Assurance including SOP development
- Audits and support for Inspections for all global regulatory authorities
Regulatory Services
- CRO Site Qualification Audit
- GCP/GLP Audit
- CSV Audit
- Vendor Qualification
- Clinical Trial Monitoring
- Review of Study date
- Regulatory Query response
