Outsourcing – The perils & pitfalls of choosing your Pharmacovigilance Partner
Pharmacovigilance has remained in the background of Pharmaceutical Companies until recently, when drug safety moved in to the media spotlight. Now, more than ever, it is essential that patient safety is seen to be of paramount importance to pharmaceutical companies.
However, many Companies still see the pharmacovigilance process as a thorn in the side, a burden, a tick box exercise in compliance, rather than a fundamental element to the long term success of a product.
The outsourcing of pharmacovigilance tasks provides a flexible solution to the ever changing demands of running a specialist pharmacovigilance team. Duties that would usually be performed in-house are contracted to a dedicated service provider, whether it is on a full service, partial or project basis. Whilst there is no doubt that outsourcing is not for everyone, there is an ever increasing argument of the benefits that outsourcing can provide.
The key element for outsourcing is the recognition from the Pharmaceutical Company that if the services are outsourced, the responsibility to monitor the safety of the Company products does not change, it remains with them and any deficiencies that occur in that monitoring also fall back on them as licence holders or Sponsors of clinical trials.
If the outsourcing partner fails to perform in a compliant manner, this reverts to the Pharmaceutical Company and so this makes the choice of the outsourcing partner even more important.
PharSafer® is committed to make sure that all of its services are conducted properly, compliantly and keep up to date with the ever changing global rules in the pharmacovigilance and medical services arena.
Our Quality Management processes and the training of our staff ensure that a professional and competent group of people will be dedicated to help ensure clients can outsource their activities confident in the knowledge that a proficient Company is monitoring patient safety thoroughly.
When is it right to outsource?
- If you need provide additional resource to support in house teams (sickness cover or specific expertise for example)
- To provide short term additional resource and activities during an expansion phase
- If you need a ‘ready to go’ fully trained team of skilled professionals
- If you need the flexibility to respond to varying workloads. The outsourcing approach of ‘pay as you go’ allows you to respond fully to regulatory obligations, without the need of retaining a full pharmacovigilance team on the payroll
What services can be outsourced?
What are the benefits of outsourcing?
Each company is different – different products, different customers, and different needs. No two outsourcing solutions are the same and that is important in any choice being made for a provider because you need your provider to be flexible to your needs rather than you trying to fit their ‘conveyor belt’ approach to service. Below is an overview of some of the key benefits that outsourcing may offer:
Choosing the right outsourcing partner – what are the risks?
Ultimately it is the Marketing Authorisation Holder (MAH) that is accountable for the safety of their products. If your outsourcing partner makes errors when performing the pharmacovigilance or Medical Information activity then you as the MAH are accountable and this can even mean receiving financial fines for non-compliance. With this in mind, it is vital that when selecting an outsourcing partner, you ask the right questions. After all, prevention is better than cure!
At PharSafer®, you can confidently answer YES to all of the above questions concerning Quality; compliance and expertise, making PharSafer® an excellent choice for your entire Pharmacovigilance and Medical Services outsource partner.
At Inspection time, you as the licence holder are the only one accountable for non-compliance, not your PV provider – why? Because it is your name on the licence and that is what is being judged – you.
Therefore, when choosing and auditing your PV & Medical Services provider, please consider the following:
Does the proposed provider:
Whatever the size of your Company or whatever your requirements may be, we can provide you with the personal and professional service your Company needs.
To discuss any of our services please contact us on + 44 (0) 1483 212150 or email Marketing@pharsafer.com