Pharmacovigilance Auditing & Training

With our team of highly trained and experienced auditors and trainers we can conduct audits and mock-up inspections that will meet your PV needs. We will work alongside you to build the best package to achieve the outcomes you desire.

Audit Programme Development

Managing and developing an audit risk assessment process, audit programme and mapping out the audit universe.

Inspection readiness support

Providing support for inspections, including scenario / role play, training etc.

Quality Management

Supporting and developing the Quality System, including procedures, work instructions, and gap analysis. Our continuous improvement programme ensures we provide you with the very best service, within which external quality audits and self-assessments are conducted.    

Our team carry out GVP audits on behalf of our clients, in which we provide a full assessment of systems and advising on areas of improvement.

Training / Workshops 

PV regulations require all personnel in the performance of PV activities within an organisation must receive initial and continued training.

PDS provide bespoke training to fit your requirements within PV, we work with you to customise training content to your needs and requirements.  

Our team here at PDS have experience in working one to one, working in small to large companies and most of all are flexible to your needs, becoming part of your team.

Some of the areas we can cover are listed below:

• PV Auditing
• Preparing for audits and Regulatory inspections
• Qualified Person for Pharmacovigilance (QPPV)
• Customised training on PV GVP Modules
• Writing case narrative
• Establishing and implementing PV Quality Management System