A Pharmacovigilance (PV) Executive plays a vital role in ensuring the safety of medicines and medical devices by monitoring, assessing, preventing and reporting adverse drug reactions. Their primary responsibility is to detect and manage any potential risks associated with pharmaceutical products throughout their lifecycle which helps maintain compliance with regulatory authorities while contributing to the protection of public health.

Key Responsiblities and Requirements

The key responsibilities and day-to-day duties of a PV Executive include adverse event processing and literature reviews, with the findings being reported to the appropriate competent authorities. This information is also compiled into comprehensive reports, such as risk management plans and product safety reports.  We also ensure that the product information (e.g. Summary of Product Characteristics and Patient Information Leaflets) are consistently updated through regular reviews, comparing against brand leaders and the latest scientific literature. The role also involves responding to medical information requests from healthcare professionals or patients and significant training responsibilities. This may be training new team members on pharmacovigilance processes and quality checking their work or educating customers and marketing authorisation holders on the types of safety information they need to pass onto us.

The Role Within Callisto

The role as a PV executive at Callisto involves extensive collaboration with various departments, whether it’s participating in regular meetings with fellow PV colleagues to discuss ongoing projects, working closely with the quality department on the development and refinement of the QMS, debating complex cases with medical reviewers, or coordinating with the regulatory team to organise submission timelines. This cross-functional teamwork provides a unique opportunity to gain a comprehensive understanding of the entire drug lifecycle – from development through to post-market monitoring.

The role of a Pharmacovigilance Executive at Callisto is also not solely focused on human medicines; we also offer veterinary pharmacovigilance and medical device vigilance services. I am particularly involved with the veterinary side, which I thoroughly enjoy. I am involved in the initial setup of veterinary customers within our QMS and the ongoing reconciliations with these customers, making sure that safety data is continually reviewed and updated. Most recently, I have been working on updating our veterinary pharmacovigilance system to comply with the new VMD legislation that was published earlier this year. This has been an exciting and important project, as it ensures our ability to maintain the highest standards in safety monitoring.

Summary of a PV Executives Role

To summarise, the most exciting aspect of being a PV Executive is the diverse skill set you develop and the dynamic nature of the role. No day is ever the same, which keeps the work both engaging and rewarding. One day, you might be working individually, processing adverse event cases and the next, you could be contributing to a large project and collaborating with cross-functional teams to address the needs of a customer with an international presence. This global aspect also adds an extra layer of complexity and opportunity, as it often requires adapting to different pharmacovigilance guidelines, such as those from the WHO, MHRA, EMA and other local regulatory requirements specific to individual territories.