Pharmacovigilance Consultancy Support
Nucleus Pharma has a team of scientific and medical experts with broad experience in all areas of pharmacovigilance. As a result, we can provide guidance and support (including drafting and/or review) in the development/update of Standard Operating Procedures (SOPs)/working practices supporting Pharmacovigilance
- All employee PV training
- Safety data exchange agreement authoring and maintenance
- Global safety committee activities
- Signal management and Risk minimisation activitiesdevelopment/Maintenance of company core datasheet maintenance (CCDS) and labelling committee governance
- Safety variations and Urgent safety restrictions
- Handling safety information from product quality complaints and medical enquiries; including safety information from solicited activities (e.g. registries, market research, patient support programs, company' sponsored social media activities)
In addition, our team can support with:
On-site or remote development and provision of all employee PV training materials
- Safety data exchange agreements authoring
- Adverse event and pregnancy forms development
- Development of educational materials for risk minimisation and creation of targeted questionnaires for specific patient groups, AEs or other safety concerns
- Benefit-risk communications with competent authorities
- Review/input into clinical trial protocols, investigator brochures and clinical study reports
- On-site or remote regulatory inspection support before, during and after the inspection
- Conducting on-site or remote audits of internal global and affiliate PV departments; as well as audits of contractual partners/providers
- Provision of consultancy support on safety database, including due diligence, set-up, validation and data migration activities