Pharmacovigilance and Drug Safety

Pharmacovigilance: To Outsource Or Not To Outsource, That Is The Question

Pharmacovigilance is the pivotal process for ensuring a company’s products remain on the market. In reality the business faces the challenges of increasingly complex and constantly changing worldwide regulations, requiring higher levels of inter-disciplinary expertise, together with demands to improve public safety. The safety arena continues to be in the media spotlight so it is important that the patient is the primary focus and Pharmacovigilance is handled effectively with the correct tools to detect and respond to any safety concerns with a product.

Many Pharma companies have increased the number of qualified staff to comply with these strict reporting requirements and increased workload but are now facing economic pressures due to shrinking budgets. Therefore it is important to scrutinize costs, as more is expected with less available resource.

Outsourcing occurs when an organisation employs a contract service provider to perform services that would normally be performed “in-house”. Outsourcing is undertaken by companies to reduce fixed overhead costs, avoid high upfront investments, secure additional capacity, increase resource flexibility or augment the performance of an activity that is not considered a core area of the business.

Off-shoring occurs when the work is outsourced to lower cost countries such as India or China rather than Europe or the US to reduce the labour costs. However there can be disadvantages as quality will suffer where staff have insufficient knowledge of the worldwide regulations and limited Pharmacovigilance experience or training.

It is possible for a company to outsource the entire Pharmacovigilance function or specific aspects only. However it is important to remember that although the Marketing Authorisation Holder (or manufacturer in the US) can delegate some or all Pharmacovigilance activities it must retain overall responsibility for the safety of the products.

What are the benefits of out-sourcing on an interim basis or for specific projects?

• To fill any gaps in a Pharmacovigilance team such as in times of sickness, maternity leave, during periods of recruitment or training of staff.
• To fill short-term skill gaps to help in times of workload peaks
• Use of a virtual team works as and when projects demand and allows for particular individuals to be brought in when specific expertise is required
• Use of interim staff can bring in strategic direction to a company without huge investment
• Benefit in expertise in a specific area by use of personnel who are effective from day one
• Ability to tap into highly specialist areas as and when needed and quickly
• Flexibility – you only pay for what you use so do not incur costs of a full-time salaried position

What are the benefits of outsourcing the Pharmacovigilance System?

• The technical requirements of operating and supporting a regulatory compliant Pharmacovigilance system can be expensive and very sophisticated and may exceed the skills of the company IT team
• The associated software and other Pharmacovigilance system costs require scalability and cost structures that Pharmacovgilance Service Providers can accommodate
• Pharmacovigilance systems upgrade or replacing an existing system can be costly and time consuming. The migration of data from different systems can be expensive and difficult
• Use of an off-site Pharmacovigilance system may be less expensive than in-house installation
• Does not require the large first year cost normally accrued with an in-house system
• Outsourcing can provide an immediate, multi-location Pharmacovigilance network with minimal IT investment