Pharmacovigilance Services in Switzerland

Switzerland’s pharmacovigilance framework is precise, inspection-driven, and nationally distinct from the EU despite alignment with international standards. Companies marketing products in Switzerland must meet Swissmedic-specific post-marketing surveillance, local safety oversight, and reporting requirements.

DDReg provides Pharmacovigilance Services in Switzerland designed for pharmaceutical, biotech, and life sciences companies that require inspection-ready Swiss pharmacovigilance execution, not theoretical compliance. As a trusted Swiss drug safety service provider, we combine global PV governance with deep operational knowledge of Swissmedic expectations.

In Switzerland, Marketing Authorisation Holders are required to designate a Qualified Person Responsible for Pharmacovigilance (QPPV).

• The QPPV does not need to reside in Switzerland
• The QPPV must be appropriately qualified, with documented experience across all aspects of pharmacovigilance
• The QPPV must have sufficient authority to ensure compliance with Swiss pharmacovigilance obligations
• The QPPV must be continuously available to respond to Swissmedic safety queries and inspection requests

While physical presence in Switzerland is not mandatory, Swissmedic expects effective national oversight, clear escalation pathways, and immediate access to safety data relevant to the Swiss market.

DDReg provides Swiss QPPV services that meet Swissmedic’s qualification, availability, and accountability expectations, supported by structured local operational oversight.

• Swiss Therapeutic Products Act (TPA)
• Ordinance on Pharmacovigilance (Vigilance Ordinance)
• Swissmedic Pharmacovigilance Guidance
• ICH Guidelines (E2A, E2B(R3), E2C, E2E)
• WHO Pharmacovigilance Standards

• + Individual Case Safety Report (ICSR) Management
  • End-to-end ICSR intake, medical assessment, and quality review
  • Management of serious and non-serious adverse events
  • MedDRA coding and Swissmedic-compliant safety narratives
  • Swissmedic ICSR reporting services via the ElViS system
  • ElViS portal submission support, including follow-ups and acknowledgements
• + Aggregate Safety & Post-Marketing Surveillance
  • Ongoing post-marketing surveillance Switzerland support
  • Preparation and review of periodic and ad-hoc safety analyses
  • Alignment of Swiss safety data with global pharmacovigilance systems
  • Inspection-ready safety documentation and consistency checks
• + Signal Detection & Risk Management
  • Continuous signal detection and safety trend evaluation
  • Swiss-specific safety impact assessments
  • Swiss Risk Management Plan (RMP) writing and lifecycle updates
  • Support for risk minimisation measures and safety communications
• + PV System Setup, Maintenance & Audit Support
  • Design and maintenance of Swissmedic-aligned PV systems
  • SOP development tailored to Swiss pharmacovigilance obligations
  • Gap analysis, mock audits, and Swissmedic inspection preparedness
  • End-to-end pharmacovigilance outsourcing Switzerland models
• + Swiss QPPV & Local Safety Officer Support
  • Swiss QPPV services through senior pharmacovigilance professionals
  • Appointment and operational support for Local Safety Officer (LSO) Switzerland
  • Swissmedic authority communication and safety query management
  • Integrated local–global safety governance models
• + Local Literature Screening & Monitoring
  • Local literature screening Switzerland across Swiss and international sources
  • Case identification, triage, and documentation compliant with Swissmedic guidance
  • Integration of literature cases into global safety databases
  • Ongoing compliance monitoring

Why Choose DDReg as Your Swiss Pharmacovigilance Partner

• Proven experience delivering Swiss pharmacovigilance services
• Trusted Swiss drug safety service provider for global and regional MAHs
• Deep expertise in Swissmedic pharmacovigilance support and inspections
• Scalable pharmacovigilance outsourcing Switzerland solutions
• Operational reliability across clinical, post-approval, and lifecycle stages