Clinical Safety Operations Manager
il y a 2 semaines
We are seeking a highly skilled Clinical Safety Operations Manager to join our team at ICON. As a key member of our Global Drug Safety function, you will be responsible for contributing to effective and efficient proactive safety strategies for assigned processes and delivery of operational safety aspects.
Key Responsibilities- Develop and optimize 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 non-interventional post-authorization studies in close collaboration with the Vendor Manager.
- Review safety sections of trial-related documents, such as Drug Safety Manual/Safety Processing Plan, Trial Oversight Plan, and SAE reconciliation plan.
- Contribute to trial-specific resource and budget planning.
- Collaborate with relevant partners/service providers of sponsors and align guidelines and processes related to clinical trial safety management with existing GDS processes.
- Health Care Professional with extensive work experience in pharmacovigilance, clinical development, project management, and 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.
- Several years of professional experience (5-7 years) 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 the safety of drugs in development and post-authorization.
- Excellent communication skills in an international environment.
- Intercultural experience through successful collaboration in matrix teams.
- Competitive salary and benefits package.
- Opportunities for career growth and professional development.
- Diverse and inclusive work environment.
- Recognition and rewards for high performance.
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il y a 8 heures
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il y a 3 semaines
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il y a 3 semaines
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Clinical Research Operations Manager
il y a 3 semaines
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Clinical Research Operations Manager
il y a 3 semaines
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il y a 8 heures
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il y a 4 semaines
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