The themes of the training must be adapted to the professional role and responsibilities of a staff member. Of course, there would be some specific training that should be covered for all pharmacovigilance professionals. Table 1 presents a list of topics to be covered by all pharmacovigilance staff. Table 2 presents themes specific to the function of pharmacovigilance. A well-trained staff is essential for every pharmaceutical company or a CRO. Effective and effective management of training needs can be achieved by carefully planning and identifying employees` needs and adapting them to the company`s objectives. With proper planning and execution, the company can effectively and efficiently manage all of its pharmacovigilance compliance requirements. A far-sighted approach to training is to have a training department as a mandatory function of the department of pharmacovigilance. This function should be as important as it could be given to the quality assurance unit, as it is the two important pillars of a successful pharmacovigilance division. An effective approach to ensure that training is of the importance it rightly deserves, the authors recommend that training outcomes be the “key outcome area” of each employee and that a “real measure” of the effectiveness of the training system “is not subject to observations” regarding training outcomes in all systems that can be reviewed or verified. A unique aspect of the requirement for pharmacovigilance activities is that, with the growth of pharmaceutical and biotechnology companies, the requirement for this function will always increase, as if the products are older on the market, the requirement for pharmacovigilance and the performance of regulatory obligations continue to exist. With the addition of new products in companies, the function continues to grow. Increased revenues lead to increased sales, resulting in increased prescriptions and, consequently, increased population exposure.

Finally, it means that more qualified people are needed to manage the increase in the number of adverse reactions and all the resulting pharmacovigilance activities with respect to reporting to regulators. The supply and demand situation for skilled workers is highly distorted in favour of demand, given that this sector is relatively new in India and elsewhere, and a large number of pharmaceutical companies are relocating this function to India to benefit from cost arbitrage. So the workforce with long experience and wide exposure is limited at this stage. Therefore, the need for qualified resources to become highly qualified pharmacovigilance professionals is the need of the moment. Even in cases where self-training is required, an evaluation of this particular theme can be planned. This would require a frequent trip by the coach or intern. These can also be managed by web-based training or video conferencing, taking into account the time difference between the two locations. Another option is to have a trainer on the isolated site when the training needs on this site are high in terms of number of apprentices and training.

The purpose of this course is to give you an overview of the nature and use of pharmacovigilance agreements and to understand the content of a pharmacovigilance agreement.