Pharmacovigilance (PV)

CSO Pharma supports you to fulfil your Pharmacovigilance obligations as Marketing Authorisation Holder 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-System

  • 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 (Set-Up and Assessment)

Literature / MLM /  PSURs

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

Risk minimisation measures

  • Realisation of safety measures (i.e. graduated plan procedure, recalls)
  • Implementation of risk minimisation activities (i.e. educational material)
  • Socialvigilance
  • Training on Pharmacovigilance topics, processes and tools 
  • Safety- and compliance surveys

QPPV, Safety Officer

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

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)

Audits

  • Pharmacovigilance Audits
  • Support of internal audits
  • Audit management including corrective- and preventive actions (CAPA)
  • Regulatory inspection readiness 

Pharmacovigilance Agreements

  • Preparation of Safety Data Exchange Agreements (SDEAs)
    Update of contracts

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

Audits

Pharmaceutical companies are regulatory obliged to ensure internal and compliance of contracted partner through audits >>

PV-Training

CSO Pharma actively supports you with trainings on Pharmacovigilance. To accomplish more with profound knowledge >>

Processes - SOPs

CSO Pharma implements processes, SOPs & related interfaces and gives answers on up-to-dateness, completeness and validity >>

Contact

Do you have a question - please feel free to contact us.
T +49 (0) 89 2033 53 59
F +49 (0) 89 809 193 80

Or just send an email to