SG CONSULTING Privatpraxis Integrated Pharmacovigilance & Research Laboratory
SG CONSULTINGPrivatpraxis    Integrated Pharmacovigilance & Research Laboratory 

ISO 9001:2015 Reg. Nr. 731005745

Mitglied der PBV 

Privatärztlicher Bundesverband e.V.

„Hope, vision, and well-being for each patient through integrated clinical practice, education, and research“

PHARMACOVIGILANCE MANAGEMENT SERVICES

 

SG Consulting is specialized in supporting in-house safety teams that face increased workloads, special projects, legal case support or backlogs, and operates within client’s standard practices and workflows to integrate external gold-standards and validated resources at every point possible.

Service solutions are scalable and available on an as-needed basis.
Some examples include:

 

  • Collection and regulatory evaluation of individual case safety reports (ICSRs) from the post-marketing surveillance systems for pharmaceutical and medicinal products;

  • Comprehensive ICSR case processing including narrative writing and data entry into the client’s database, including ICSRs expedite reporting;

  • Medical and/or scientific review of case reports of serious adverse events (SAEs) from clinical trials, and regulatory reporting of suspected unexpected serious adverse reactions (SUSARs);

  • Expert MedDRA coding;

  • Answering to medical-scientific enquiries from healthcare practitioners and/or patients, and answering to pharmacovigilance authority requests;

  • Critical appraisal of medical and scientific literature for pharmacovigilance;

  • Local (German) literature monitoring in the post-authorization phase for active pharmaceutical ingredients;

  • Safety signal identification and management;

  • Legal/litigation case review and management;

  • Medical information; performing gap analyses on product information and providing expert guidance on remediation activities in areas of non-compliance;

  • Generation and writing of cumulative, global safety reports (e.g. PSURs, PBRERs) according to the Good Pharmacovigilance Practice (GVP) - Modules VI, VII and IX, including interpretation of the aggregate data, and qualitative and quantitative evaluation of the benefit / risk of medication in various patient populations;

  • Generation, writing and update review of European Risk Management Plans (RMPs) according to the GVP Modules V and VI;

  • Generation, writing and update review of Development Safety Update Report (DSUR) for ongoing clinical studies;

  • Documenting SOPs and assisting clients with the set-up and implementation;

  • Documenting cross-functional SOPs relating to patient safety;

  • Designing, developing and delivering training courses customized to specific needs, and interdisciplinary training of personnel on medical-scientific aspects of pharmacovigilance;

  • Intensive collaboration with client’s pharmacovigilance-relevant internal and external functions and with the Competent Authorities;

  • Preparing and improving existing SDEAs between clients and licensing partners, ensuring that safety information is transferred in a timely manner.

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