Pharmacovigilance compliance, drug safety oversight and risk management support
FMS Baltic provides pharmacovigilance consulting services to pharmaceutical companies, marketing authorisation holders (MAHs) and life sciences organisations.
We support the establishment, maintenance and evaluation of pharmacovigilance systems to help organisations meet applicable safety monitoring and reporting obligations.
What We Offer
- Assessment of pharmacovigilance system requirements and compliance gaps
- Development and review of pharmacovigilance procedures and standard operating procedures (SOPs)
- Support for the preparation and maintenance of Pharmacovigilance System Master Files (PSMFs)
- QPPV interface and local contact person for pharmacovigilance (LCPPV) support and coordination, where required under national rules
- Pharmacovigilance agreements and oversight of outsourced activities
Drug Safety Reporting
- Individual Case Safety Report (ICSR) process assessment and support
- EudraVigilance reporting requirements, ICSR process review and compliance assessments
- Periodic Safety Update Report (PSUR/PBRER) coordination and review
- Safety signal management process support
- Assessment of reporting responsibilities and timelines
Risk Management and Safety Compliance
- Risk Management Plan (RMP) preparation and review support
- Risk minimisation measures and their implementation
- Evaluation of pharmacovigilance compliance obligations
- Support for corrective and preventive action (CAPA) planning
- Pharmacovigilance training and procedural improvement
Pharmacovigilance Audits and Inspection Readiness
- Pharmacovigilance system gap assessments
- Audit preparation and inspection readiness support
- Review of pharmacovigilance documentation and processes
- Assessment of vendor and service provider oversight
- Follow-up support for audit and inspection findings
Flexible Pharmacovigilance Support
FMS Baltic provides project-based pharmacovigilance consulting, specialist subcontracting and support for defined safety compliance activities.
Assignments may include individual system assessments, documentation reviews, procedural improvements or coordination of ongoing pharmacovigilance responsibilities.
Discuss Your Pharmacovigilance Requirements
Contact FMS Baltic to discuss your pharmacovigilance system, drug safety reporting or compliance support needs.