Working in the pharmacovigilance department can be a ‘happening one’ or even a roller-coaster ride. This is irrespective of whether you work for a pharmaceutical company, service provider, monitoring centre, or regulatory agency. Dealing with the rigmarole is going to be a rewarding experience and a satisfying one as you ultimately contribute to the welfare of public health.

Changing regulations

This is very common, although the extent of change is unpredictable. The situation may be complex for multinational pharma companies with operations in multiple countries. An efficient regulatory intelligence system may help in early notification and thus minimise the impact of the change.

Audits and Inspections

Announcement of audits and inspections is routine, and one cannot escape this. Sometimes the regulatory inspection (or even the audit) may be unannounced. The only way to tackle this is by ensuring audit readiness at all times.

Automation

Automation, artificial intelligence, and machine learning are no longer the fad words. We need to accept these, and the management also needs to accept it. Automation is here to stay! We only need to put this to the right use for enhancing the quality of work, risk management of products, and expediting the identification of safety signals.

Changing the Safety Database

One may encounter a situation where the management decides to change the safety database due to some reason (commercial or compliance), or the vendor notifies that they will no longer support the present version of the company’s safety database. You have no option but to change the database or upgrade it. The impact may be huge, as you must consider safety data migration, validation, training and even administrative updates in the quality management system.

Outdated Product labels

This may come up as a surprise during the inspection or audit and may have a critical impact on public health. It is essential that the product labels are updated on a real-time basis and that accurate safety information is available to the prescribers and consumers.

Cross-functional non-compliance

For a successful outcome during an audit or inspection, the cross-functional teams with safety interfaces must have compliant systems. Adequate governance through internal audits can ensure that compliance is in place at all times.

Product Diversion and Counterfeit

Such situations may be beyond the control of the manufacturer or the licence holder. However, monitoring carefully and establishing adequate communication channels and risk management strategies is essential. If the product has abuse/misuse potential, e.g., narcotics, analgesics, tranquillizers, etc., one needs to inform the regulatory agencies or file a police complaint.

Recall or withdrawal

Product recall or withdrawal may be due to various reasons and can impact patient safety. This is irrespective of the geographical location where this has been identified. This may even trigger an unannounced inspection.

Organizational Changes

Organizational changes may be related to the structure of the Pharmacovigilance department or even the location and administrative facilities associated with it. Most of the time, it must be well planned, with adequate change controls in place. It may be beyond the control during mergers and acquisitions, but the Pharmacovigilance activities cannot be interrupted. The location and contact details of the Pharmacovigilance function must be current at all times. Otherwise, there is a risk of missing important safety notifications/alerts.

Mergers & Acquisition

M&A, be it the pharma entity or the service provider, is very common these days. Product acquisitions, divestments, out-licensing or in-licensing can significantly impact Pharmacovigilance. The regulatory agencies are also closely monitoring these; hence it is all the more necessary.

Lawsuits

This is the last thing a person working in the pharmacovigilance function wants to hear about. The patient or their relatives/caretakers/lawyers may file a lawsuit due to a serious adverse event.

There is no way that one can escape such testing times. After all, this is the reason that one is paid for! Despite all the hassles, it is still quite satisfying to work in the pharmacovigilance function as one is contributing to the welfare of public health.