Pharmacovigilance à France

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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 KPIs, implement, monitor and communicate performance and develop solutions for continuous improvements. Ensure sponsor required compliance by vendors involved in clinical trials and non-interventional 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 IMP/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 clinical trial safety activities in collaboration with relevant partners/service providers of the 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, clinical development, project management, IT Systems
• Fluent in written and spoken English
• University degree or relevant professional experience equivalent to scientific studies
• Proven project and process management skills

Professional Experience

• 5-7 years of professional experience in Drug Safety/Clinical Trial Safety Management
• Leading or attending Drug Safety Monitoring Committee meetings
• Drafting and using ICFs
• Sound understanding of regulations relevant to drug safety in development and post-authorization
• Excellent communication skills in an international environment
• Intercultural experience through successful collaboration in matrix teams

Our success depends on the quality of our people. That’s why we’ve made it a priority to build a diverse culture that rewards high performance and nurtures talent.

In addition to your competitive salary, ICON offers a range of additional benefits, focused on well-being and work-life balance for you and your family. Examples include:

• Various annual leave entitlements
• A range of health insurance options
• Retirement planning offerings
• Global Employee Assistance Programme, TELUS Health
• Life assurance
• Flexible country-specific benefits like childcare vouchers, gym memberships, travel passes, health assessments, among others

Visit our careers website to learn more about working at ICON. We are an equal opportunity employer committed to a workplace free of discrimination and harassment. If you need a reasonable accommodation during the application process or to perform your job, please let us know or submit a request.

Interested in the role but unsure if you meet all requirements? We encourage you to apply — you might be exactly what we’re looking for, whether for this or other roles.