Senior Clinical Safety Professional

Category: Reg Affairs & Safety Pharmacovigilance

Location:Søborg, Capital Region of Denmark, DK

• Anticipating the impact of changes to case handling processes on interconnected and related processes.
• Contributing to the updates of standard operating procedures (SOPs)/working instructions demonstrating independent Subject Matter Expert expertise within the field of case handling.
• Participation in projects in Global Patient Safety, e.g., contribute to the oversight, support and coordination of outsourcing activities to CRO and ensuring integrations of new molecules in Safety Operations processes.
• Involvement in presentation of Safety Operations processes at inspections and audits.
• Managing dedicated clinical trials, serving as the primary contact from case handling team for relevant stakeholders on larger clinical trials concerning specific safety issues.
• Involvement in the trial initiation phase for all types of clinical trials, where you will ensure trial set-up that supports case handling activities, and you will act as mentor for colleagues on these trials. Moreover, you will be part of our case management trial initiation group.

• B.Sc. degree and/or M.Sc. degree, registered nurse or equivalent within health science.
• Documented strong experience and understanding of processes and regulatory requirements within pharmacovigilance, and clinical trial regulation.
• Documented extensive hands-on experience within safety case handling.
• Strong understanding of clinical trial and project management processes.