Pharmacovigilance Consulting
For any company, ensuring the safety of its medicines is a critical priority.
At Harten Group we understand the challenges you face and the specialist expertise required to overcome them.
With over 350 specialist pharmacovigilance consultants registered with us, we have a wealth of highly qualified industry specialists to draw on.
Whether you need an interim to deliver immediate operational assistance to meet a short-term need or a more strategic review of a wider drug safety issue, we can find the appropriate people.
Over the last 16 years, we have supported 100 companies’ drug safety operations, on a wide range of PV projects. These have included providing interim physicians and/or Qualified Persons to support departments through to undertaking complex, international management consulting reviews of departmental operations to identify deep-rooted issues or problems.
We are happy to meet for a confidential discussion of your needs - please contact Dr Vernon Harten-Ash on +44 (0)1223 233777.
With an inspection looming, we were concerned about some aspects of our drug safety operation and called in a team from Harten Group to help us prepare. It resulted in some training and restructuring which paid immediate dividends: the inspection went really well and no critical findings were identified.
CEO, Pharma Company
Highlighting PV expertise
In order to promote our significant expertise in the area of pharmacovigilance, Harten Group has placed advertisements in the December and March issues of Pipeline magazine, the official publication for the Pharmaceutical Information & Pharmacovigilance Association. PIPA is the professional organisation for individuals who are involved in the provision and management of information and those involved in the fulfilment of regulatory requirements relating to drug safety.
It highlights our capability in terms of providing interim QPPVs, pharmaceutical physicians and senior drug safety managers to the industry. With over 350 specialist pharmacovigilance consultants registered with us, we have 16 years' experience of supporting 100 companies' drug safety operations on a wide range of PV projects.
In the March issue we also published an article on inspections and how to turn them into a positive experience.
A further advertisement is scheduled to appear in the June issue of Pipeline.
Latest assignments
Interim EU QP (PV)
6-12 Months
Oncology Medical Director
Interim or Permanent
Interim Senior Regulatory Affairs
3-6 Months
Recent projects & updates
A consultant has been helping a generics company headquartered in Ireland, currently branching into branded pharmaceuticals, with training and raising awareness of the Code to ensure local and UK compliance.
Harten Group consultant handles all regulatory requirements for compiling and submitting monthly safety updates for a global pharma company's antiviral during recent flu epidemic.