First of all, I belong to a drug safety division in a pharmaceutical company, and therefore this case study was very interesting. As a matter of fact, a drug safety division is often said to be Pharmacovigilance (PV) division in the pharmaceutical industry. According to the World Health Organization (WHO), "Pharmacovigilance (PV) is defined as the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problem. (World Health Organization. (n.d.))"
I briefly explain what a PV division is performing. A PV division submits individual case safety reports and periodic safety reports to regulatory authorities in accordance with regulatory requirements of each country …show more content…
For success of a project, it is necessary to have an organic collaboration that allows people in charge to communicate with other team members regardless of which sub-team the person in charge belongs to. This case certainly made it possible to clarify roles and responsibilities among project teams and sub-project teams. However, there were cases in which cooperation among teams became difficult. My impression is that each person in charge is not only responsible for his/her own tasks but rather having a wide range of knowledges in PV operations. Furthermore, when promoting a project, it is necessary to be a team, not a group. According to the MBA Management Book (2008, pp. 198-199), the group is an aggregate that obtains the result that summed up the ability on performance achievement of each member. On the other hand, the team is a form of group; it is an aggregate that can expect more than the total of each member's ability on performance achievement. To sum up, I think that it is critical to organically collaborate within a project team. In particular, a safety database is the system that is a basis of a PV system. Therefore, for the success of this project, I believe that …show more content…
On the other hand, I think that cross-team problems could not be solved. For example, even if you develop a technically superb system with the Global IS Lead, it should be a user-friendly for people in charge of the Global User Lead who actually input safety information to the safety database. Actually, as I mentioned at the beginning, I have also worked as an evaluator in order to submit individual case safety reports to regulatory authorities. What can be said from that experience is that there are many items to enter information in a safety database system to comply with regulatory reporting requirements. Therefore, it is essential to proceed the project in line with the business goal of complying with regulatory requirements by repeatedly solving issues between Global IS Lead and Global User Lead, so that such new safety database will be mutually beneficial for
I briefly explain what a PV division is performing. A PV division submits individual case safety reports and periodic safety reports to regulatory authorities in accordance with regulatory requirements of each country …show more content…
For success of a project, it is necessary to have an organic collaboration that allows people in charge to communicate with other team members regardless of which sub-team the person in charge belongs to. This case certainly made it possible to clarify roles and responsibilities among project teams and sub-project teams. However, there were cases in which cooperation among teams became difficult. My impression is that each person in charge is not only responsible for his/her own tasks but rather having a wide range of knowledges in PV operations. Furthermore, when promoting a project, it is necessary to be a team, not a group. According to the MBA Management Book (2008, pp. 198-199), the group is an aggregate that obtains the result that summed up the ability on performance achievement of each member. On the other hand, the team is a form of group; it is an aggregate that can expect more than the total of each member's ability on performance achievement. To sum up, I think that it is critical to organically collaborate within a project team. In particular, a safety database is the system that is a basis of a PV system. Therefore, for the success of this project, I believe that …show more content…
On the other hand, I think that cross-team problems could not be solved. For example, even if you develop a technically superb system with the Global IS Lead, it should be a user-friendly for people in charge of the Global User Lead who actually input safety information to the safety database. Actually, as I mentioned at the beginning, I have also worked as an evaluator in order to submit individual case safety reports to regulatory authorities. What can be said from that experience is that there are many items to enter information in a safety database system to comply with regulatory reporting requirements. Therefore, it is essential to proceed the project in line with the business goal of complying with regulatory requirements by repeatedly solving issues between Global IS Lead and Global User Lead, so that such new safety database will be mutually beneficial for