Pharmacovigilance Services in Germany

If you are a pharmaceutical manufacturer, healthcare provider, or life sciences organization operating in Germany, access to pharmacovigilance services in Germany is critical to ensuring drug safety and regulatory compliance. From adverse drug reaction reporting to compliance with BfArM pharmacovigilance regulations, the right PV partner shapes signal detection, risk management planning, safety reporting, and successful market authorization.

The Federal Institute for Drugs and Medical Devices (Bundesinstitut für Arzneimittel und Medizinprodukte, BfArM) is the national authority responsible for post-market safety surveillance of pharmaceuticals in Germany. Clinical trials often do not capture all adverse drug reactions, especially rare ones. These might emerge only after the product is on the market. Under the German Medicines Act, BfArM is legally obligated to continuously collect, evaluate, and act upon safety information for approved products. The Pharmacovigilance Division ensures that patients, healthcare professionals, and other stakeholders are informed about risks and mitigation measures.

• + ICSR Processing & Submission
  • Triage of initial and follow-up ICSRs, SUSARs
  • Case Processing through E2B(R3) compliant databases and other relevant databases integrated with Drug dictionary (WHO DD) and MedDRA
  • Quality Check, Medical reviews
  • Submission of cases as per agency timelines
  • Maintaining ICSR monitoring & tracking sheets
  • Reconciliation process with customers
• + Risk Management Plan
  • Drafting, reviewing, and maintaining RMPs and REMS while providing support through submission methods
  • Preparing customized procedures to classify safety risks and deliver tailored risk management plan pharmacovigilance
  • Assessment of potential risks and missing information and prepare reports that recommend risk management methods
  • Implementation of supplementary measures, including Post-Authorization Safety Studies (PASS), such as developing academic materials, observational examinations, and targeted follow-up questionnaires
  • Effectively convey risks through labelling documents – i.e Prescribing Information & Medical Guides (PIL)
• + Aggregate Reports
  • Periodic Safety Update Report (PSURs)
  • Development Safety Update Reports (DSURs)
  • Annual Safety Reports (ASRs)
• + Signal Management
  • Identification of new safety signals and/or changes in risks concerning a pharmaceutical product from ICSR database, literature, aggregate reports as well as regulatory agency website monitoring
  • Utilizes a variety of in-house tools and databases for signal detection and tracking signal management processes
  • Reviews safety signals for ICSRs, aggregate reports and recommendations by Pharmacovigilance Risk Assessment Committee (PRAC)
  • Performs label update analysis
  • Provide recommendations from signal assessments which include risk minimization approaches
  • Preparation of Signal Management Tracker, Annual Signal Reports
• + Qualified Person/Qualified Person for Pharmacovigilance (QPPV)/(QP) Services in Germany
  • Review of PSMF, SDEA agreements, agreements with commercial partners, PV SOPs etc
  • Retainer services for QPPV Services and Deputy
  • Local Safety Responsible
  • Monthly reconciliation
  • Medical review of Signal detection; Signal Surveillance Meetings (Quarterly)
  • Monthly Communication report/provision of compliance metrics
  • PV Quality Management System Oversight
• + PV Audit & Compliance
  • Review PV Audit and Compliance to applicable PV guidelines, regulations, Safety Data Exchange Agreements (SDEAs), SOPs (standard operating procedures) and work instructions
  • Optimize well-constructed audit plans as well as mock audits to prepare customer organizations for PV inspections conducted by respective competent authority
  • Conduct regular gap assessments of PV staff at site location
  • Provide organizational training on safety audits and inspections
  • Deliver mock audits and gap assessments to ready your organization for inspections