Vigilance services for health products

YMUNIT covers the full lifecycle of pharmacovigilance, medical-device vigilance and cosmetovigilance activities: system design and implementation, governance and procedures, case and signal management, periodic reports, post-market surveillance, audits, provider oversight, inspection readiness, due diligence and team training. Final regulatory accountability remains with the organisation concerned.

Yes. All or part of pharmacovigilance operations can be outsourced: outsourced pharmacovigilance leadership, outsourced QPPV and back-up, case management, signal management, periodic reports, vendor oversight and international coordination. Scope, responsibilities and back-up arrangements are defined according to the marketing-authorisation holder’s status and applicable regulatory requirements.

An outsourced QPPV is a Qualified Person for Pharmacovigilance provided by a service provider to perform, supervise or complement the QPPV function of an operator or marketing-authorisation holder. The arrangement, availability and back-up are tailored to the product portfolio and applicable requirements; the marketing-authorisation holder’s regulatory accountability is not transferred.

A QPPV back-up ensures continuity in the event of absence, leave, temporary vacancy or departure of the appointed QPPV. It provides uninterrupted oversight of the pharmacovigilance system, case processing and regulatory obligations.

Pharmacovigilance monitors adverse reactions to medicinal products (GVP), medical-device vigilance monitors incidents involving medical devices (MDR/IVDR), and cosmetovigilance monitors undesirable effects associated with cosmetic products. All three share the same logic — collection, assessment, reporting and corrective action — but operate under distinct regulatory frameworks.

Yes. YMUNIT performs GVP audits, pharmacovigilance-system audits, provider audits (CROs and safety vendors), affiliate audits, gap assessments and due diligence. Audits are organised with appropriate separation between operational responsibilities and independent assurance work.

GVP inspection readiness is based on an initial assessment, document review, mock inspection, preparation of teams and evidence, support during the inspection, analysis of findings and follow-up of CAPA plans.

Yes. YMUNIT audits CROs, safety vendors and vigilance providers: compliance with contracts and vigilance agreements, KPIs and SLAs, quality of case and signal processing, and deviation and CAPA management. Findings are documented in a report and remediation plan.

Concrete, immediately usable deliverables: audit report, gap assessment, remediation plan, CAPA plan, accountability mapping (RACI), procedures and SOPs, PSMF, Safety Management Plan, vigilance agreements, dashboards and KPIs, inspection-readiness plan, due-diligence report, transfer and continuity plans, executive reporting and training programme.

Transfer is prepared from the outset: documentation, procedures, handover pack, team training and capability development, role-transition support and continuity plan. YMUNIT can operate the function while it matures and then transfer it progressively. See also our outsourced leadership for governance and transformation.