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.
Responsibilities
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 providing expertise and guidance to Global Drug Safety functions, other company functions, and vendors for safety operational tasks. The Manager is responsible for developing, optimizing, implementing, and documenting processes to ensure Pharmacovigilance compliance. Define process KPIs, monitor performance, and develop solutions for continuous improvements. Ensure vendor compliance in clinical trials and post-authorization studies in collaboration with the Vendor Manager.
* Manage medical safety follow-up queries for ICSRs from clinical trials and post-authorization studies, including SAE reconciliation activities.
* Oversee reconciliation of ICSRs exchanged with partners and sources like Global Medical Information.
* Maintain the study protocol library and the company product dictionary in the safety database (ARISg).
* Review safety sections of trial documents such as Drug Safety Manual, Safety Processing Plan, etc.
* Contribute to resource and budget planning for trials.
* Align clinical trial safety activities with partners and service providers, ensuring adherence to guidelines and processes.
Qualifications Education / Languages
* Health Care Professional with extensive experience in pharmacovigilance, clinical development, project management, or 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 experience in Drug Safety / Clinical Trial Safety Management.
* Experience leading or participating in Drug Safety Monitoring Committee meetings.
* Experience drafting and using ICFs.
* Understanding of regulations related to drug safety in development and post-authorization.
* Excellent communication skills in an international environment.
* Intercultural collaboration experience in matrix teams.
What ICON can offer you :
Our success depends on the quality of our people. We prioritize building a diverse culture that rewards high performance and nurtures talent.
Along with a competitive salary, ICON offers various benefits focused on well-being and work-life balance, including:
* Annual leave entitlements.
* Health insurance options.
* Retirement planning options.
* Global Employee Assistance Programme, TELUS Health, offering 24/7 support.
* Life assurance.
* Flexible country-specific benefits such as childcare vouchers, gym discounts, travel passes, and health assessments.
Visit our careers website to learn more about working at ICON.
ICON is an equal opportunity employer committed to a workplace free of discrimination and harassment. We consider all qualified applicants equally and provide accommodations for those with disabilities or medical conditions.
If you're interested but unsure if you meet all requirements, we encourage you to apply — you might be exactly what we're looking for.
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