Outsourcing pharmacovigilance activities can increase flexibility, provide access to specialised expertise and support increasingly complex global operations. But outsourcing an activity never means outsourcing accountability.
This December, PVpharm’s CEO José Alberto Ayala Ortiz will have the pleasure of joining pharmacovigilance colleagues, regulators and industry experts at the European Pharmacovigilance Congress 2026 (EUPV) in Milan.
The European Pharmacovigilance Congress brings together professionals from regulatory agencies, international pharmacovigilance organisations, patient organisations, industry and academia. The 2026 programme covers 27 topics and places particular emphasis on safety science, regulatory compliance, operational excellence, new technologies and effective communication.
I will be speaking during Session 27: PV Audit & Inspections, on 4 December, with a presentation entitled:
A 5-Step Guide to Inspection-Ready PV Subcontracting
The presentation will focus on an issue that has become increasingly important for Marketing Authorisation Holders (MAHs): how to subcontract pharmacovigilance activities effectively while maintaining appropriate oversight, control and inspection readiness.
Outsourcing activities, not responsibilities
Pharmacovigilance outsourcing is now an established part of the operating model of many pharmaceutical companies.
Case processing, literature screening, local pharmacovigilance activities, medical information interfaces, aggregate reporting support, safety database activities and other PV processes may involve external partners.
The challenge is not simply selecting a competent service provider.
The real challenge is ensuring that the resulting operating model continues to work as one coherent pharmacovigilance system.
For an MAH, this means having sufficient visibility and control to understand:
- who is responsible for what;
- how safety information moves between organisations;
- which timelines and quality standards apply;
- how performance is monitored;
- how deviations, CAPAs and changes are managed;
- and whether the arrangement can withstand regulatory scrutiny.
This distinction is fundamental: a contractual relationship may define responsibilities between two organisations, but regulatory accountability and effective oversight require much more than a signed agreement.
From vendor qualification to continuous oversight
One of the central ideas is that inspection readiness should not start when an inspection is announced.
It should be designed into the subcontracting model from the beginning.
In practical terms, José will present a five-step approach covering the lifecycle of a PV outsourcing relationship, from the initial definition of activities and responsibilities through qualification, contractual governance, operational oversight and continuous assurance.
The objective is not to create more bureaucracy.
Quite the opposite.
A well-designed governance model should make responsibilities clearer, escalation faster and evidence easier to retrieve. It should enable both the MAH and its partners to understand how the outsourced process actually works and demonstrate that control when required.
The inspection-readiness test
A useful question for any MAH working with pharmacovigilance service providers is:
If an inspector asked us tomorrow to demonstrate control over this outsourced activity, could we provide clear, consistent and traceable evidence?
Answering “yes” requires more than SOPs and contractual documentation.
The organisation should be able to demonstrate how oversight works in practice: governance meetings, performance metrics, reconciliation, quality issues, CAPAs, training, audits, escalation pathways, changes and documented decisions.
Inspection readiness is therefore not a document.
It is an operating condition.
And this is particularly important in an increasingly distributed PV ecosystem, where one activity may involve the MAH, a global service provider, local affiliates and additional subcontractors.
A session focused on audits and inspections
The Session 27: PV Audit & Inspections, is chaired by Calin A. Lungu, CEO of DDCS S.A. The programme also includes contributions from Elena Giovani of AIFA, subject to confirmation, Michelle English of Ireland’s HPRA and Lucia Biagiotti of PL Italia.
The session will conclude with a round-table discussion bringing together representatives and experts from organisations including AIFA, HPRA, Jazz Pharmaceuticals, Pfizer, Shionogi Europe, Fidia Farmaceutici, DDCS and PVpharm.
That combination of regulatory, industry and service-provider perspectives should make for a particularly valuable discussion.
Looking forward to Milan
The face-to-face part of the European Pharmacovigilance Congress takes place in Milan on 3-4 December 2026, following the virtual programme on 18-19 November.
At PVpharm, we work every day with organisations dealing with the practical realities of pharmacovigilance operations, compliance and outsourcing. I am therefore particularly pleased to bring some of those experiences and lessons learned to the EUPV community.
If you are attending the congress, José would be delighted to meet you in Milan.
Join us on 4 December at 16:30 for “A 5-Step Guide to Inspection-Ready PV Subcontracting” and the subsequent Session 27 round table.
Because successful PV outsourcing is not simply about delegating work.
It is about building a relationship that remains controlled, transparent and inspection-ready throughout its lifecycle.
