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

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What services can be outsourced?

• Full pharmacovigilance outsourcing service (development/clinical and post marketing)
• Full medical information outsourcing service offering 24/7/365 coverage
• Case processing
• Literature searching
• Signal detection activities and Benefit-Risk assessments
• EU QPPV provision & National QPs (where required)
• PSUR/PBRER/DSUR/RMP/REMs writing
• Electronic reporting setup
• (EXVMPD) – Product registration on the European Product Database
• Safety agreement production & maintenance
• Audit preparation and conduct activities
• Quality Management Activities
• Training
• Clinical Safety assessments and reporting
• Integrated summaries of safety (ISS)
• Core Safety production and SPC/Patient leaflet assessments
• SOP writing and updating

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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:

• IT departments may not have the expertise to support the highly technical requirements of establishing and maintaining a pharmacovigilance database or supporting the validation aspects to ensure Regulatory compliance. With supply and set up costs approximating £200,000 + it is often cheaper to have an off-site service provider than establish a database in house, provision of staff, associated training and usual department running costs without incurring these costs yourself. Equally, the backup of safety data, disaster recovery and business continuity aspects are also complicated and expensive (but expected by Regulatory Authorities) and so you need a supplier with a robust set up to successfully supply these for you.
• Specialist providers are able to ‘hit the ground running’ in providing pharmacovigilance and Medical Information support. Whether you are seeking an experienced EU QPPV (Qualified Person) service only, report writing services or an entire team, specialist providers are able to provide near immediate expertise for matters pertaining to complex global pharmacovigilance and Medical Information regulations, expertise which may not be readily available in house.
• For growing and even virtual companies, who may have little experience in pharmacovigilance, outsourcing affords the opportunity to have technical experts leading their pharmacovigilance activities, without the commitment of employing a full time team or increasing and sourcing that team since this too is the responsibility of the service provider. The remote operation reduces the business overheads whilst retaining a close communication flow between provider and client.
• Resource constraints. Once you have the provider in place, it is their responsibility to ensure that they have the correct number of properly trained individuals to perform all of the aspects of Pharmacovigilance and Quality assessments so that you remain compliant and to keep them trained with the ever increasing and changing regulations. So, if you increase the number of products you have, increase the number of countries your products are licensed in, and so increase sales, then it is the provider’s responsibility to increase staff numbers to cope adequately with the increased number of adverse reactions.
• Global knowledge. As your product portfolio grows and the number of countries you license your products then the greater the requirement for detailed local knowledge of all of the requirements to ensure that you remain globally compliant.

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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!

• What is your first impression of the outsourcing partner? Are they well organised? Professional? Responsive to your needs?
• Will they provide named pharmacovigilance and account management contacts for you to contact at any time?
• Will the provider have a  zero tolerance approach for errors which means that if they do not process something correctly you will have this provided free of charge because of their approach to total Quality?
• Will you receive free Regulatory updates to warn of changes pending to systems and processes so that you know you are prepared and your provider has taken appropriate action?
• Will/does your provider have a training department to ensure that staff are always trained to the latest global safety requirements?
• Will your partner provide you with training in Pharmacovigilance that you understand? If their training department cannot train you, how can they train their own staff?
• Will the partner provide free monthly reports on account activity levels and compliance?
• Will the partner provide matrices and trend lines for PV activities and Medical Services?
• Will the partner give you a free report on a quality assessment for processed cases and medical enquiries?
• Will the partner give you copy of an internal annual audit performed on themselves by an external PV consultancy (worth £15,000) that highlights any deficiencies and CAPAs to save you having to do your own audit and at the same time give you comfort that you have a partner always looking to improve?
• Will/does your provider tell you of the problems but not suggest the solutions?
• What do your peers say about the provider?  Pharmacovigilance and Medical Services is a small world!
• Has your provider volunteered for a Regulatory systems Inspection? This benefits you as a client because if they pass you will be inspected less. If they have not – why not?

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:

• Focus on how cheap they are and not the experience of their staff
• Not want to commit to signing up on any agreement that involves Quality targets
• Does not want to inform you of any other client that has had a bad Inspection involving them
• Cannot demonstrate their own training programmes for staff – or want to train you in PV – if they cannot train you how can they train themselves?
• Show you their own Quality Management System.

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

From day one, we are PharSafer® – shouldn’t you be?

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