Pharmacovigilance contractual documents

Pharmacovigilance Agreements (PVA), Safety Data Exchange Agreements (SDEA) and Safety Management Plans (SMP) are some of the terms used to describe the contractual documents which outline the responsibilities between the MAH (or Sponsor) and Pharmacovigilance Service Providers, and which are vital when contracting Pharmacovigilance Services. However, as highlighted by the MHRA GPvP Inspectorate in their recent article, the content of these documents is not always adequate for the management of the outsourced activities and this is a risk for pharmacovigilance (PV) non-compliance.

Contractual document content

The following areas require attention when constructing contracts for pharmacovigilance services:

  • Audits, gap analysis and capacity planning
  • Clarity of record and data ownership, and access to data (QPPV & NCA)
  • Defined records management
  • Terms for transition periods & provisions for business continuity
  • Proportionate oversight tools (audit, KPIs, deviations), workload metrics & training
  • PSMF and Article 57 XEVMPD content and maintenance responsibilities
  • CAPA implementation & dispute resolution

Pharmacovigilance non-compliance

Service Providers do not work for free and will only perform the services that they are explicitly contracted to conduct. The MAH is responsible for PV compliance. Therefore, any activities which are not included in the contract with the Service Provider must be performed by the MAH. So, the MAH must be able to:

  • Fulfil the requirements for record-keeping in support of safety data analysis and decision‑making
  • Maintain a complete safety database
  • Establish a means of access to their safety database and records in the event of a request from competent authorities (e.g. inspection, safety data assessment questions)
  • Ensure that critical PV activities can be undertaken continuously (i.e. account for business continuity risk)
  • Ensure data integrity, especially during data transfers

Oversight and communication

The MAH and Qualified Person for Pharmacovigilance (QPPV) must have oversight of the systems and access to the data of the whole pharmacovigilance system and if problems arise, have the authority to ensure problems are resolved. Therefore, to ensure transparency between parties, good practice is to include regular updates and clear communication channels within the contractual documents. MAHs should be aware that they may need to assist with risk and impact assessment and/or CAPA development for non-compliances arising from another organisation’s governance or inspection activities. Contracts should include requirements for audits across all parties and for the sharing of inspection and audit findings that have a potential impact on the pharmacovigilance system compliance.

System performance

MAHs need to be able to confirm that the minimum standards are applied with regard to performance (must be accurately reflected in the PSMF):

  • Documentation of the appropriate selection of service providers and auditors
  • Sharing of information about risk and non-compliance, including information arising from inspections, deviations, key performance indicators (KPIs) or audit
  • Appropriate resourcing and training provision, which may require capacity planning reporting on workload/activity,
  • QPPV has sufficient training and capacity to fulfil the role

How EUDRAC can help

The EUDRAC PV Department undertakes the compilation of these contractual agreements on behalf of its clients. These are constructed specifically to ensure both the limit for failure within the PV system, and also that all stakeholders are fully aware of their responsibilities. For further information, please see the EUDRAC pharmacovigilance webpage.