Must possess expertiseknowledge sufficient to adequately perform the duties of the job being offered. Expertiseknowledge may be gained through employment experience or education. Such expertiseknowledge cannot be quantified by time. Required expertiseknowledge includesbr br Detailed knowledge of major aspects of Pharmacovigilance PV for the analysis of risk profiles arising from different kinds of PV business models.br Understanding of PV legislations and global regulatory aspects of Pharmacovigilance.br Knowledge of the PV relevant legislations, regulatory framework and standards.br Experience in major aspects of PV to evaluate possible safety issues that might arise from contractual arrangements and to perform riskbased maintenance of PVcontracts.br Understanding of business models and impact on PV accountability.br Understanding of crossfunctionalmatrix type of work teams including knowledge of local and global business processes and governance structures.br Knowledge of the principles of internal and external audits and inspections.br Technical skills with Document Management Systems and Contract Management System.br br The years of experience listed in H.6 and H.10 do not apply to the required skills listed in this section.br Employer will accept any suitable combination of education, training, or experience.
Categories: eb3
0 Comments