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What Do Inspectors Check for Safety Data Exchange Agreement Roles and Responsibilities?

Safety Data Exchange Agreements must define clear pharmacovigilance roles and responsibilities between the MAH, partners, and service providers. Regulators expect explicit ownership of case handling, reporting, follow-up, reconciliation, oversight, and escalation.

For: Founders, CEOs & MDs·PV Leads·QA/Compliance·Scientists tasked with documentation

Alignment: Global pharmacovigilance principles (ICH-aligned) and inspection practices

Most useful when: Preparing for inspection, setting up a process, or closing a documentation gap

Key points

  • Safety Data Exchange Agreements must define roles and responsibilities clearly for all pharmacovigilance activities covered by the relationship.
  • Responsibility allocation must distinguish between activities performed by the MAH, partner, and service provider.
  • The MAH must retain ultimate accountability for pharmacovigilance compliance even where activities are delegated or shared.
  • Agreements should explicitly define ownership of case intake, follow-up, submission, aggregate reporting, signal management, literature monitoring, reconciliation, and escalation.
  • Responsibility matrices should align with actual operational practice and avoid gaps or overlap.
  • Inspection-ready evidence should demonstrate that responsibility allocation is current, explicit, and understood by all parties.

What inspectors expect

Each point below should be supported by controlled documents and traceable records.

  • Pharmacovigilance roles and responsibilities must be allocated clearly between all parties.
  • Responsibility allocation must cover all activities performed under the agreement.
  • The MAH must retain ultimate oversight and accountability.
  • Delegated tasks must not create ambiguity, duplication, or gaps in compliance.
  • Agreements must reflect how activities are actually performed in practice.

Summary

Inspectors assess whether Safety Data Exchange Agreements allocate pharmacovigilance roles and responsibilities clearly across the MAH, partners, and service providers. They typically review ownership of case handling, reporting, reconciliation, oversight, and escalation, and check whether the MAH retains effective control of the pharmacovigilance system.

Common questions

These are the questions this page is designed to answer directly.

  • What roles and responsibilities should be defined in an SDEA?
  • How do inspectors assess SDEA responsibilities?
  • What must the MAH retain responsibility for in pharmacovigilance?
  • How should partner responsibilities be defined in an SDEA?
  • What responsibilities can be delegated to a PV vendor?
  • How are pharmacovigilance responsibilities divided between parties?
  • What do inspectors check for MAH oversight in an SDEA?
  • How should responsibility matrices be structured in pharmacovigilance agreements?
  • Who is responsible for ICSR reporting under an SDEA?
  • How do you document PV accountability between companies?

Evidence objects inspectors expect

Responsibility Matrix

  • Allocation of ICSR intake, processing, and submission responsibilities
  • Defined ownership of follow-up and reconciliation activities
  • Role allocation for aggregate reporting and signal management
  • Distinction between primary responsibility and support functions
  • Clear identification of MAH, partner, and vendor obligations

Safety Data Exchange Agreement Role Clauses

  • Defined pharmacovigilance responsibilities for each party
  • Explicit ownership of day zero recognition and case forwarding
  • Defined responsibilities for literature screening and health authority correspondence
  • Escalation and communication obligations
  • Contact list and named PV representatives

Operational Governance Evidence

  • Joint safety committee records
  • Meeting minutes confirming responsibility review
  • Escalation logs for unresolved accountability issues
  • Evidence that responsibilities are reviewed when the agreement is updated

MAH Oversight Controls

  • Evidence that the MAH reviews partner or vendor compliance
  • Audit rights and oversight provisions
  • Tracking of partner or vendor performance against agreed responsibilities
  • Defined escalation routes where delegated tasks are not performed correctly

Regulatory Basis (Primary Sources)

  • GVP Module I – the MAH remains responsible for the pharmacovigilance system and quality oversight
  • GVP Module VI – responsibilities for collection, exchange, and reporting of ICSRs must be defined clearly
  • ICH E2D – post-approval safety data responsibilities and exchange expectations
  • MHRA GPvP guidance – expectations for MAH accountability and oversight of contracted activities
  • FDA postmarketing safety reporting guidance – compliance responsibility remains with the application holder

Typical Inspection Questions (What Inspectors Ask)

  • Who is responsible for case intake and case forwarding under this agreement?
  • Who submits ICSRs to the relevant authority?
  • How do you ensure the MAH retains oversight of delegated activities?
  • Show me the responsibility matrix for this partner or vendor relationship.
  • How do you manage responsibilities that sit across both parties?

Failure patterns

Responsibilities are vague or split in a way that creates operational ambiguity.

The agreement does not clearly identify who owns key pharmacovigilance activities.

The MAH assumes tasks are being performed by the partner or vendor without effective oversight.

Responsibility matrices are incomplete or inconsistent with the written agreement.

Actual operational practice does not match the documented role allocation.

What good looks like

  • A clear and current responsibility matrix covering all relevant pharmacovigilance activities.
  • Explicit identification of who performs, supports, reviews, and oversees each activity.
  • Clear MAH accountability and active oversight of delegated work.
  • Alignment between the SDEA, responsibility matrix, and actual operational practice.
  • Named contacts and escalation pathways supporting accountability.

Operationalisation

  • Define all pharmacovigilance activities covered by the relationship before drafting role allocation.
  • Allocate each activity to a clearly identified party and distinguish ownership from support.
  • Confirm that the MAH retains oversight of all delegated or shared obligations.
  • Use a responsibility matrix to support the written agreement and operational training.
  • Review role allocation whenever processes, territories, or service models change.
  • Test responsibility allocation during governance reviews, audits, and reconciliations.

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FAQ

What roles should be defined in a Safety Data Exchange Agreement?

An SDEA should define responsibility for case intake, forwarding, follow-up, submission, aggregate reporting, literature monitoring, signal management, reconciliation, regulatory correspondence, and oversight.

Does the MAH remain responsible if activities are delegated to a vendor?

Yes. The MAH remains ultimately responsible for pharmacovigilance compliance even where operational activities are delegated to a vendor or service provider.

What is the purpose of a pharmacovigilance responsibility matrix?

A responsibility matrix helps show clearly which party owns, supports, reviews, or oversees each pharmacovigilance activity under the agreement.

Do inspectors review responsibility allocation in SDEAs?

Yes. Inspectors frequently review SDEAs and responsibility matrices to confirm that role allocation is clear, current, and aligned with actual practice.

What are common role allocation failures in pharmacovigilance agreements?

Common failures include unclear ownership, duplicated tasks, gaps in accountability, weak MAH oversight, and mismatches between the written agreement and operational practice.

Who is ultimately responsible for pharmacovigilance under a Safety Data Exchange Agreement?

The Marketing Authorisation Holder (MAH) remains ultimately responsible for pharmacovigilance compliance, even where activities are delegated or shared with partners or service providers.

Who is responsible for ICSR submission under an SDEA?

The responsible party should be explicitly defined in the agreement, but regulatory accountability generally remains with the MAH or the entity holding the relevant reporting obligation in that territory.

Sources

Primary guidance used to inform this map. This page is a structured interpretation layer; always validate against the original source documents.

European Medicines Agency (EMA)

  • Guideline on good pharmacovigilance practices (GVP) – Module I
    View source
  • Guideline on good pharmacovigilance practices (GVP) – Module VI
    View source

International Council for Harmonisation (ICH)

  • Post-Approval Safety Data Management: Definitions and Standards for Expedited Reporting (E2D)
    View source

U.S. Food and Drug Administration (FDA)

  • Postmarketing Safety Reporting for Human Drug and Biological Products
    View source

UK MHRA