Clinical Safety Manager

Working in ICON Strategic Solutions is more than a job, it’s a calling for people who care and have passion for improving patients’ lives. It takes courage to move from one job to another and the process involves careful consideration. At ICON, we care about our people as they are the key to our success and provide an open and friendly work environment where we empower people and provide them with opportunities to develop their long-term career.

All our team members have the independence to get the job done with support from the experienced leadership team when you need it. If you want a career with a difference, ICON Strategic Solutions is the place for you.

The role of the Manager Clinical Safety Operations is to contribute to effective and efficient proactive safety strategies for the assigned processes and delivery of operational safety aspects. This includes the provision of key expertise and guidance to concerned Global Drug Safety functions and other functions within the company, as well as vendors for safety operational tasks. In addition, the Manager Clinical Safety Operations is accountable for the development, optimization, implementation, and documentation of appropriate processes to ensure Pharmacovigilance compliance in the area of responsibility. Define process KPls, implement, monitor and communicate performance and develop solutions for continuous improvements. Ensure sponsor required compliance by vendors involved in clinical trials and noninterventional post authorization studies in close collaboration with the Vendor Manager

The Manager Clinical Safety Operations is responsible and accountable for:

• Process for the medical safety follow-up queries for ICSRs from interventional clinical trials and non-interventional, post-authorization studies SAE reconciliation activities (interface to Global Data Management) for company sponsored phase I to IV clinical trials and non-interventional post -authorization studies
• Process for reconciliation of ICSRs exchanged with business/development partners and other sources (Global Medical Information)
• Maintenance of the study protocol library (with assignment of IM P/ non -IMP) and the company product dictionary in the global safety database (ARISg)
• Review of safety sections of trial related documents (e.g. Drug Safety Manual/ Safety Processing Plan, Trial Oversight Plan, SAE reconciliation plan)
• Contribute to trial specific resource and budget planning OM001-BP-T01/Version 5.0/Effective: 08-March-2021 (Ref. OM001-BP) 
• Contribute to defining and implementing of clinical trial safety related activities in the alliance with relevant partners/service providers of sponsor and alignment of guidelines and processes related to clinical trial safety management with existing GDS processes

Education/Languages

• Health Care Professional with extensive work experience in pharmacovigilance area, clinical development, project management, IT Systems
• Fluent in written and spoken English
• University degree is an advantage or relevant professional experience equal to scientific studies
• Proven project and process management skills

Professional Experience

• Several years of professional experience (5-7 years) in Drug Safety/Clinical Trial Safety Management
• Sound understanding of regulations relevant to the safety of drugs in development and post authorization
• Excellent communication skills in an international environment
• Intercultural experience through successful collaboration in matrix teams