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.