Pharmacovigilance

• Expedited reporting 
• PSUR reporting 
• Responding to information requests form the competent authorities
• Handling of urgent safety restrictions and safety variations
• Continuous monitoring of the safety profile of authorised medicinal products and notifying competent authorities and health professionals of changes in the risk/benefit assessments
• Meeting CHMP commitments (for centrally registered products)
• Maintaining internal audits of the pharmacovigilance system

• Responsibility as EU qualified person for pharmacovigilance (EU QPPV)
• Responsibility as a local QPPV in Germany (Stufenplanbeauftragter), Austria, the Netherlands, Belgium and Luxembourg
• Development of Pharmacovigilance systems 
• Preparation and Maintenance of Pharmacovigilance System Master File (PSMF), Summary PSMF (S-PSMF) and standard operating procedures (SOP) n
• Assistance with competent authority inspections, self-inspections and audits
• Management and evaluation of adverse events and complaints 
• E2B (R3)-compliant processing and reporting of ICSRs
• Literature research
• EudraVigilance database monitoring for authority reports and signals
• Signal management and continuous benefit-risk analysis 
• Periodic safety update reports (PSURs)
• Risk management plans (RMPs) and risk minimisation activities (such as educational material)
• Company core data sheet (CCDS) and product information
• Data submission and maintenance in the eXtended EudraVigilance Medicinal Product Dictionary (xEVMPD)
• Contract management, such as the preparation and maintenance of safety data exchange agreements (SDEAs)
• Pharmacovigilance training

• Establishment and maintaining of pharmacovigilance systems
• Case Processing
• Signal Management
• Literature search
• Medical information
• EU QPPV (Qualified person for pharmacovigilance)
• Pharmacovigilance audits
• Medical Writing

ProPharma Group GmbH is a leading consultancy and project management organisation in the fields of (bio)pharmaceutical products, medical devices, and healthcare.

Contact us in any phase of your product's lifecycle if you are looking for a partner in Product Development, Regulatory Affairs, (Pharmaco)vigilance or QA/QC.

• Adverse Event Management (pre- and post-authorization)
• Qualified Person for PV (EU and local)
• Periodic reports (PSURs, DSURs, other safety reports)
• Risk Management Plans
• PV training and education
• SOP writing and literature review
• PV System Master File set-up 

• Establishment of a EU-QPPV or Local QPPV in various EU countries
• Gap-Analysis, Elaboration and Maintenance of the PSMF and other PV SOPs;
• Establishment of the Qualified Person / Responsible Person for EudraVigilance including the xEVMPD Registration and the Establishment of the ICSR electronic Reporting;
• Elaboration of the Technical Agreements - Safety Data Exchange Agreement;
• Elaboration of CIOMS Reports;
• Signal Management;
• Compliance Reports;
• Local and Worldwide Literature Monitoring;
• Periodic Reconciliation with the Clients;
• Pharmacovigilance in Clinical Trials;
• Performance of Pharmacovigilance Audits and issuance of the applicable Audit Reports;
• Periodic Safety Update Reports;
• Elaboration of Risk Management Plans (QPPV drafting, assessment or renewal updates, signatory service in case of full-service PV);
• Local QPPV in countries with the mandatory (in EU) requirements (BE, BG, HR, CY, CZ, DK, FR, EL, HU, LV, LT, NL,PL, PT, RO, SK, ES)

PharmaLex is a leading provider of specialized services for the pharma, biotech and medical device industries.

We guide you from early strategic planning activities and non-clinical requirements through clinical development, regulatory submission processes and post-approval / maintenance post-launch activities. Our experts use technology enabled solutions to support you through the entire product lifecycle. We deliver exceptional results — going above and beyond the standard to deliver tailor-made solutions worldwide. 

The PharmaLex Group now has over 1000 employees, with 33 offices in 21 countries and more than 600 satisfied clients worldwide.

• Pharmacovigilance & Clinical Safety
• ICSR management, including collection, evaluation, processing, distribution and reporting (incl. validated safety database)
• Signal management
• Risk management
• Periodic safety reports
• Pharmacovigilance system and compliance
• EU-QPPV, local QPPV
• Quality system, audit and inspection support
• Safety data exchange agreements
• Pharmacoepidemiology
• Literature Surveillance