Pharmacovigilance (PV) is essential for patient safety but is still often seen as a burden for companies within the pharmaceutical industry. Changing global and local regulatory requirements, advances in technology and increased awareness of adverse drug reactions are just some of the considerations that can make PV a challenging and often complex area.
Pharmaceutical companies are now expected to demonstrate a more proactive approach to patient safety with regulators increasingly focusing on compliance, including the timely reporting of adverse events (AEs) and periodic reports, proactive risk management and on the quality of the reported information. This approach requires robust quality systems and experienced professionals which can be both costly and resource intensive for pharmaceutical companies with an in-house function. There is additionally the challenge of attracting and retaining talented staff for in-house PV, which can be particularly difficult when scaling up the PV operations to meet the demands of a growing business.
An alternative to the traditional in-house model is the outsourcing of PV work to a specialist company. Outsourcing is a solution that allows the delegation of the PV responsibilities to specialist service providers as a full or partial bespoke service. Whilst the responsibility for monitoring safety ultimately remains with marketing authorisation holders (MAHs) and Sponsors, this allows experts in areas of pharmacovigilance that are ever changing to provide a high quality and fully compliant service. Outsourcing PV responsibilities can be invaluable for small to mid-sized businesses looking to grow, but it can also be a great choice for larger businesses as it can free-up internal resource, increase efficiency, and potentially reduce overall costs.
The size of the pharmacovigilance outsourcing market exceeded 3.8 billion US dollars in 2019 and is expected to grow by 15.8% between 2020 and 20261.
Improved management and quality of pharmacovigilance responsibilities can mitigate risks through increased compliance, productivity and improved strategic outcomes. However, outsourcing has its own challenges and creating and maintaining a good client relationship in both business and PV is vital for a successful partnership.
Creating a successful PV Outsourcing Partnership
Arranging an introductory meeting at the beginning of the working relationship and having at least one face-to-face meeting can be a great way to begin building rapport. In the current climate, with a large number of staff continuing to work remotely, this may be challenging, however video calling or even just a regular phone call shouldn’t be overlooked when looking to make introductions.
Maintaining regular communication between client (MAH/Sponsor) and the service provider is vital to ensure transparency and compliance. As a service provider, there needs to be a balance of providing excellent customer service whilst also providing technical expertise and guidance to the client to reach a solution that both parties are happy with.
Regular meetings, including technical meetings, are beneficial to discuss ongoing and upcoming work, to feedback any processes or areas identified for improvement and to ensure the client’s needs are being met. Demonstrating to a client that they are being actively listened to can go a long way to establishing confidence in the service.
A single point of contact, such as a designated contact person or a dedicated email address, can often be a good way to establish a working relationship with clients. This allows frequent communication with a timely response and can help to increase client satisfaction.
Providing flexibility and a tailored approach to individual clients are both essential in order to deliver the best service possible. Flexibility is key when providing a full or partial outsourcing service in order to complete multiple projects, some of which may have a short turn around due to regulatory requirements.
Providing a tailored approach allows the client to feel assurance in the service being delivered and creates collaboration between parties. A collaborative effort allows innovation and development of processes and the service provider can help to improve existing processes in line with their expert knowledge.
Being open to change can be key to providing that flexibility. This is especially true in an industry such as PV where there is a huge variety of potential clients from small companies with specialised medicines, to large multi-national businesses with global portfolios. Being able to adapt or even completely change processes in order to accommodate a client’s individual needs will provide a strong foundation for success in the long term.
Monitoring required and available resources, especially qualified staff, on a regular basis ensures that responsibilities and compliance are maintained at all times. Resourcing is an area where flexibility is vital for service providers as factors such as new clients, new medicinal products, client acquisitions or additional licences in new countries may lead to additional workload.
Assessing each project effectively to estimate the resource required for completion can aid with appropriate staffing. However, this can depend on a number of factors which should be taken into account including the size of the project, the deadline and whether it is fixed term or an ongoing basis. Once the resource required has been established for a project, this should be revisited regularly in order to monitor effectiveness.
Service providers are often sought for their expertise and detailed knowledge of both global and local requirements and so training is a vital area. The need for internal or external training and also refresher training should be assessed on a regular basis.
Clients are also vital when considering the need for training and often are an invaluable resource for expertise in their medicinal products. New products or new licences may require provision of training to service providers and is beneficial for higher quality outputs.
Transparency is key to creating and maintaining a successful technical relationship with a client. PV is an area with complex regulatory requirements that can often result in tight reporting deadlines and so any non-compliances should be communicated and flagged by either party straight away. Errors should always be minimised through the use of robust systems, however being honest and transparent when an error has occurred will prevent any further non-compliances and can go a long way in gaining a mutual trust between client and service provider.
Transparency is also essential in relation to project costs, including how long the project may realistically take and the resource and training required, and ensuring that this is communicated in a clear manner.
PV outsourcing is a growing market due to the increasing complexity of regulatory requirements. Maintaining client relationships and in particular technical support is vital to ensure ongoing transparency and compliance. Collaboration will ultimately improve PV specialist knowledge and increase the safety of client products.
How can Panacea help?
Panacea is a consultancy company which has been working on behalf of clients since 2009 to provide a wide range of supporting services including PV, regulatory affairs, quality management and auditing.
Our technical teams are flexible and responsive, helping clients in a variety of ways; whether it is a one-off task, a fixed-term project (large or small) or a continuous relationship over a number of years. We know that each client has different needs and approaches; each has a specific budget, timescale, and objective, and we work tirelessly to ensure that all client objectives are achieved. Quality and efficiency underpin everything we do, and this is achieved through a working culture that is facilitated by a highly motivated and stable workforce.
Panacea’s relationship-focused style, in combination with a ‘right first time’ approach, ensures that our clients realise the operational efficiencies that are expected when outsourcing technical activities.
To discuss the issues raised in this article, or to request a business proposal, please e-mail: firstname.lastname@example.org
Ugalmugle, S. and Swain, R., 2020. Pharmacovigilance Outsourcing Market Size By Service. [online] Global Market Insights. Available at: <https://www.gminsights.com/industry-analysis/pharmacovigilance-outsourcing-market> [Accessed 14 October 2020].