MSI Pharma are working with an exciting rare disease focused pharmaceutical company that are seeking an experience Pharmacovigilance Physician to join their Drug Safety Team.
The Global Safety Lead (GSL) establishes and maintains the safety strategy for assigned projects/products based on strong knowledge, identifying potential challenges, risks and obstacles and develops solutions to address them, working cross-functionally with other departments. The GSL acts as the senior safety representative on cross-functional development teams and post-marketing product teams. The GSL is responsible for the medical evaluation of potential signals as part of signal management activities.
As a PV Physician (PVP), the GSL is also responsible for medical evaluation of Individual Case Safety Reports (ICSR) for assigned products, for safety monitoring of global scientific/medical literature for assigned products, and for providing input to and reviewing periodic aggregate safety reports (e.g., PSUR/PBRER, DSUR, etc.) as well as safety-related regulatory submission documents (e.g., Common Technical Documents modules, responses to regulatory authority ad hoc requests for information, etc.)
The GSL/PVP contributes to the maintenance of the pharmacovigilance system and processes.