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.
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.
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.
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? 17
