Qualified Person for Pharmacovigilance (QPPV)
Documentation and analysis of case data
Preparation of periodic reports, such as Periodic Safety Update Reports (PSUR) and Annual Safety Reports (ASR) and ad hoc reports
Review of PSUR reports and providing of QPPV confirmation and Expert Opinion
Signal detection and risk-benefit analyses, Patient safety and risk management support
Literature searches for case identification and reporting
Medical information services
Knowledgeable responses to healthcare provider and patient inquiries on your behalf—managed by skilled and sensitive medical professionals, which includes: Sharing product information, such as: usage, side effects, drug-drug interactions, disease applications and optimizing effectiveness Comprehensive contact center and reporting services Development of frequently asked questions (FAQ) database for company responses to medical inquiries Supporting challenging products, such as those that are complex, controversial or have not yet gained market acceptance
Training courses on PV and device vigilance regulations and procedures
Contact center
Professionally staffed call center by knowledgeable, specially trained, responsive healthcare professionals Leveraged contact methods most convenient for your target audience (phone, email, fax, etc.) Customer relationship management services
Medicalix
