This includes receiving the safety data from the public and from health professionals, triage of routine cases to determine seriousness, entry of the data into a validated pharmacovigilance database, coding the narrative and providing medical review and surveillance of cases.

EXPEDITED REPORTING:

All reports of serious adverse events have to be reported to regulatory authorities within strict timescales. This expedited reporting includes electronic reporting such as Eudravigilance and usually include both expected as well as unexpected serious events.

ROUTINE REPORTING:

All reports of adverse events, serious and non-serious, expected and unexpected, must be submitted periodically to the regulatory authorities. These reports include periodic safety update reports, US periodic reports and annual safety reports. The preparation of these reports can be outsourced.

DETECTING SIGNALS:

As well as reporting events, pharmacovigilance staff must carry out exercises in signal detection to see if there are any underlying trends or issues that need to be reported.

LITERATURE SCREENING:

Likewise pharmacovigilance professionals need to carry out regular searches of the peer-reviewed literature to ensure that any mentions of their product are duly noted and reported to the competent authorities. This includes searching for potential safety issues as well as individual case reports.

QUALIFIED PERSON:

In the EU, each marketing authorisation requires there to be a single point of contact, with a deputy, that is available 24-7 to act as the Qualified Person for Pharmacovigilance for Europe. Elsewhere a local Qualified Person is often required. The QP’s job is to co-ordinate the pharmacovigilance response to any safety issues that occur. QPs are required due to the complicated and convoluted structures of many pharmaceutical companies which may mean that it can be difficult to ascertain which subsidiary of which company is responsible for which product. Requiring appointment of a QP bypasses these complications.

RISK – BENEFIT:

All pharmaceutical products are supposed to bring benefits. All pharmaceutical products are associated with risks. Balancing the one against the other is the job of the pharmacovigilance  professional and of course as products stay on the market and their safety profile becomes better known, so the risk profile of a product will change.

RMP, RiskMAP, REMS

Risk management planning has become an essential part of pharmacovigilance with the requirements of submission of a Risk Management Plan in the EU and, in the US, establishment of a Risk Minimizarion Action Plan as part of a Risk Evaluation and Mitigation Strategy. Setting up and maintaining these strategies can be outsourced to pharmacovigilance specialists.

One problem with smaller, dedicated pharmacovigilance consultancies is that they won’t have the facilities to provide safety databases and expedited reporting but there are a few who can offer it, mainly through arrangements with third parties who will perform these functions on the consultant’s behalf. Amongst these consultancies the depth and range of expertise will vary widely. Some consultancies, for example the UK-based Elliot Brown Consulting, will have medically trained staff and will involve a global network of pharmacovigilance associates including former senior regulators and industry specialists. Pietrek Associates operate in a similar way. Companies such as these can often provide high end consulting, helping to deal with serious safety issues that can affect pharmaceutical products, in addition to the more run-of-the-mill pharmacovigilance activities which would include writing and review of PSURs and auditing. With such companies the costs of these consultants can seem high but it must be borne in mind that they can often turn work around faster. More experienced contractors may be able to complete a project faster than their less experienced counterparts thanks to their greater experience and knowledge.