Connecting Pharmacovigilance

a company-wide responsibility

By Janine Gavin-Poulter

Pharmacovigilance should be a company-wide global concept. However, this is sadly not always the case. As Pharmacovigilance professionals, it is not always known how Pharmacovigilance connects with different departments across the wider business. But whether you are new to the Pharma/CRO industry or an experienced PV professional, there will inevitably come a time when you will become aware of the need to connect with a different department, usually as the result of a new or updated regulation.

All the involved parts of the organisation need to remain in collaboration in order to minimise any risks to the company. Unfortunately, it’s not until the findings of an audit or inspection have been revealed that you learn the hard way that there was something that was not considered. This could be anything from the lack of sufficient oversight of a market research programme to the lack of communication regarding a company sponsored website; from not being involved in the due diligence process of reviewing safety-related data as part of product acquisitions to reviewing the product labelling for advertising to the public and healthcare professionals (HCPs). All of the involved parts of the organisation need to have a strong communicative and collaborative approach if the risks to the company are to be minimised. It is pivotal to PV compliance that other departments in a company are actively involved with pharmacovigilance requirements to ensure that the complexities of PV regulations are adhered to. The truth is, PV cannot go it alone to ensure all such requirements are met. Here, I have provided some useful information on how to make PV a company-wide responsibility. So what considerations are needed to help combat risks and drive efficiencies?

• Examine the knowledge around pharmacovigilance across departments: are personnel aware they may need input from safety and are they themselves in possession of safety-related data? Do you know who the main stakeholders are in each department?

• Identify ways to improve and teach personnel. For example, utilise PV education programmes, not just provide an industry standard PV SOP. The need to keep on proactively training is a must! • Create a robust system where changes can be implemented: this is where collaboration comes into play with your stakeholders. PV connects to many departments, from Regulatory Affairs to Medical Information, from Marketing/ Digital Marketing to Artworks, from Quality to Product Acquisitions and Sales. One question needs to be answered here: are the roles and responsibilities of the personnel in these functions clearly defined? Connecting to multiple departments is where to make a start, and it is always good practice to get to know your colleagues across the different business functions to have a clear overview of roles, where contributions are needed and ways of working together. Put it this way, if someone was to ask you what activities come under your company’s marketing function, could you answer it? Could you also answer who your main point of contact is? Are there any market research programmes, consumer research questionnaires or company sponsored websites that are either progressing, active or completed? Are you aware of all of your social media channels? Are there tools and processes in place to actively screen, collate and review product safetyrelated information? Who is responsible for this activity and are they trained? How is this communicated to PV and in what timeline? How is the data reconciled? If you have no idea…..then connect!

The table below includes some examples where PV needs to be involved (please note that this list is not exhaustive, these are purely examples). Remember that Regulatory Authorities closely look at these types of activities during an inspection, so be sure to be ready to understand your PV infrastructure and who should be involved.

Function Where PV needs to be involved

Legal Any possible safety data involving a claim should be provided to PV as per the company’s timeline

Sales

Quality Any databases, for example Salesforce, should be screened on a weekly basis to identify any potential safety data not previously sent to PV

If there is an associated AE to the PQC, this should be shared. Any risks associated with the use of a product needs to be shared with the PV team and vice-versa

Medical Affairs PV need to be included in the review of Abbreviated Prescribing Information (API) to ensure all important safety information is included as per the relevant Code(s) of Practice

Product Mergers & Acquisitions Involvement from PV is needed to review the safety profile of the product during the due diligence phase

Janine Gavin-Poulter

Vice President PIPA