About
PrimeVigilance provides pharmacovigilance (PV) services across clinical R&D, review & registration, and post-marketing phases. The company offers end-to-end PV management including collection, data entry, medical assessment and expedited reporting, global ICSR and aggregate report submission, and signal detection. They support PV plans, risk minimization measures, RMP adjustments, post-market surveillance and safety reporting, and management of seasonal vaccine ICSRs. PrimeVigilance also conducts audits and training, advises on vigilance systems and safety reporting, and helps with regulatory interactions and inspections (FDA, Health Canada, BfArM, MHRA & SUKL are mentioned). Services include support for region expansion and tailored PV research (including pediatrics).
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