Pharmacovigilance Auditing and Training

Pharmacovigilance (PV) Audits verify the implementation and operation of a PV system, including its quality system.
At JensonR+, we’ve expanded the team of our experts that are trained and experienced in conducting audits and mock inspections that meet all of your PV needs.

We’ve recently expanded our PV Auditing and Training team by taking part in the GLC Europe Pharmacovigilance Audit and Inspections EU Masterclass.

The course covered the main aspects of Pharmacovigilance audits from Planning audit programmes, how to conduct an efficient audit and how to deliver the findings through a concise audit report. The masterclass focused on audits in line with pharmacovigilance legislation especially Good Pharmacovigilance Practice (GVP) and gave clear guidance on how to check the adequacy of a PV system at a global and local level and any areas of outsourced activities.

The trainer was Joan Francesc Aregall Picamal who has over 30 years experience in many different pharmaceutical companies in both Regulatory Affairs and Pharmacovigilance.

“I found the masterclass to be very well delivered and covered all areas of interest to Jenson-R+. The trainer was very knowledgeable and was available to answer any questions we as a group had at the end of each session”.

JensonR+ Team Member

As part of our service provision, JensonR+ operate a continuous improvement programme to ensure we are providing the best service, within which we conduct self assessment and external quality audits.

Our team can undertake external audits on behalf of our clients, providing a full assessment of systems in use and and sharing advice on areas for improvement.

All staff employed within a medicinal product organisation are required to receive training to recognise potential safety information and know what to do with it. JensonR+ is able to make sure your organisation is compliant in this respect.

Get in touch with us at consultancy@jensongroup.com to find out more. 

David Lough
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