Safety Manager, Drug Safety is part of the Project Delivery organization and is responsible for management in Drug Safety/Vigilance and will work according to company policies, SOPs and regulatory requirements.
Overall responsibility of the handling of SAE in clinical trials and spontaneous reports from the market, to ensure collection, assessment and entering into the safety database in accordance with the TFS/clients’ SOPs and existing regulatory demands;
Review and approval of processed cases, AE/SAE reconciliation and safety coding;
Overview of safety activities in the department;
Responsible for plans/instructions and SOPs for post approval surveillance;
Overlook that assigned projects and tasks in the unit are performed in accordance with current routines, methods, SOPs (TFS or client´s) and current legal requirements;
Coach, support and mentor staff;
Responsible for the education and supervision of new Drug Safety personnel;
Annual performance reviews with staff including salary negotiating;
Approval of time reports and travel expenses.
Bachelor’s Degree, preferably in life science or nursing; or equivalent;
10 years of relevant experience;
Understand the medical terminology and science associated with the assigned drugs and therapeutic areas;
Understanding of the Good Clinical Practice regulations, ICH guidelines, Pharmacovigilance legislation and internal SOPs;
Excellent English written and verbal communication skills.