Pharmacovigilance Services

Pharmacovigilance Services

• Support for drug safety databases
• Individual Case Safety Report (ICSR) management: processing, quality
evaluation, medical review, and global reporting.
• Creating a Risk Management Plan (RMP).
• PSUR, PBRER, PADER, and ACOs aggregate report authoring
• Medical information management, including contact centre support
• Pharmacovigilance System Master File (PSMF/PvMF) preparation
• Pharmacovigilance Officer in Charge (PvOI), Qualified Person Responsible
for Pharmacovigilance (QPPV), and Local Responsible Person for
Pharmacovigilance (LRPV).
• Extended Eudra, Vigilance Medicinal Product Dictionary
(XEVMPD)/Identification of Medicinal Products (IDMP) entries and
• Signal detection and evaluation
• Pharmacovigilance training and consultancy
• Recommendations for designing, developing, and improving
pharmacovigilance departments
• Pharmacovigilance quality assurance, including SOP formulation;
• Audits and inspection assistance


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