The role of a PV Physician...
A physician operating within the field drug safety (otherwise known as pharmacovigilance) exists to provide analyses of complex data, ensuring that the safety profile of a medicine is identified and recognised. This revolves around assessing data for any previously recognised or newly recognised reactions a population may have to a medicine during any part of the drug development cycle. This can be a challenging process as sometimes the predictability of the data allows for these ‘safety signals’ to become more obvious, whereas with certain patient populations and/or rare disease types these signals can be harder to recognise immediately.
Depending on the size of the team you work in and whether you have a responsibility for local, regional, or global trials, a Pharmacovigilance Physician job description would usually contain some of the following responsibilities:
- Involvement in safety signal activities, including detection, evaluation and labelling
- Risk Management activities, including;
o Identifying and characterising potential risks
o Putting forward proposals and potential measures to mitigate such risks
o Responding to regulatory safety queries
o Defining the ‘risk’ side of any ‘benefit vs. risk’ assessments
- Medical review of individual case safety reports (ICSRs), which would include coding, seriousness and causality assessments
- Input into on-going reports required from the pharmacovigilance team such as regulatory submissions
- Play an important role in the internal and external implementation and then communication of medical safety strategy for your assigned drug/trial
A Pharmacovigilance Physician typically progresses from their first role by taking on further responsibility for assessments and the monitoring of larger projects or a wider geographical remit. As the physician progresses with their career they will have decision-making responsibility for local, regional or global drug safety strategy implementation. Again, as per the other specialisms already discussed in this document, a Pharmaceutical Physician in drug safety can work more towards being a ‘hands-on’ Director managing a direct team or become more of a regional project or product-based safety expert within a company.