CSO Pharma supports you to fulfil your Pharmacovigilance obligations as Marketing Authorisation Holder and Pharmaceutical Company as legally required and requested. In doing so, we offer our services likewise as hands-on partner and reliable external support.  

We develop and implement Pharmacovigilance (PV) processes and systems - according to current regulatory requirements and your needs. We support also small and medium sized enterprises to realize their own Pharmacovigilance system and give advice for improvement and harmonisation.

Pharmacovigilance Services


  • Implementation & update of the regulatory required Pharmacovigilance System
  • Human, veterinary and medical devices
  • Pharmacovigilance database and case safety report (ICSR) processing
  • Documentation with 24x7 access and QM-based management
  • Preparation and update of Pharmacovigilance procedures (SOPs) and templates 
  • Integration of Pharmacovigilance in existing QM systems (e.g. GDP, GMP, ISO) and implementation of synergies

Individual Case Safety Reports / Signal Detection

  • Processing of Individual case safety reports (ICSR)
  • Pharmacovigilance database and electronic reporting
  • Follow-up activities (i.e. ICSRs, pregnancies)
  • Signal detection, validation and analysis
  • EVDAS (Eudravigilance) Monitoring

Literature / MLM /  PSURs / RMP

  • Literature screening
  • MLM (Medical Literature Monitoring der EMA)
  • Legislation Monitoring
  • Periodic reports (e.g. PSUR resp. PBRER, DSUR)
  • Risk Management Plans (RMP)

Marketing Authorisation and regulatory documents

  • PSMF - PV System Masterfile (Module 1.8.1)
  • RMP - Risk Management Plan (Module 1.8.2)
  • ACO - Addendum to the clinical overview (Module 2)

Risk minimisation measures

  • Realisation of additional risk minimisation measures (i.e. educational material)
  • Implementation of safety measures (i.e. graduated plan procedure, PSUSA)
  • Full support with regards to recalls and Dear Healthcare Professional Communication (DHPC)
  • Training on Pharmacovigilance topics, processes and tools 
  • Socialvigilance

QPPV, Graduated Plan Officer acc. to German Drug Law

  • We also assume responsibility and act on behalf of the client as GPO according to the German Drug Law (Stufenplanbeauftragter) or as Qualified Person for Pharmacovigilance, EU-QPPV.


  • Professional Pharmacovigilance Audits
  • Support of internal audits (self inspection)
  • Audit management
  • Corrective- and preventive actions (CAPA)
  • Regulatory inspection readiness 

Pharmacovigilance Agreements

  • Preparation and Update of Safety Data Exchange Agreements (SDEAs)
  • Professional Review
  • Contract Management

Please feel free to contact us. We are looking forward to give you all the strategic and operational support you require.

QM & Pharmacovigilance

  • PV training - CSO Pharma actively supports you with trainings in Pharmacovigilance  >>
  • Processes - SOPs - CSO Pharma implements processes & interfaces and answers questions on actuality, completeness and validity of SOPs  >>
  • Audits - CSO Pharma suports you with reliable audit planning and qualified execution of internal & external audits  >>
  • Inspection Readiness - ensure that you are not caught empty-handed >>

Individual support is essential

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