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 also responsible for developing, optimizing, implementing, and documenting processes to ensure Pharmacovigilance compliance, defining process KPIs, monitoring performance, and driving continuous improvement. Ensuring vendor compliance in clinical trials and post-authorization studies in collaboration with the Vendor Manager is also key.
The Manager Clinical Safety Operations is responsible for:
* Managing processes for medical safety follow-up of ICSRs from clinical trials and post-authorization studies, including SAE reconciliation activities.
* Reconciliation of ICSRs exchanged with partners and other sources.
* Maintaining the study protocol library and company product dictionary in the safety database.
* Reviewing safety sections of trial documents.
* Contributing to resource and budget planning for trials.
* Aligning clinical trial safety activities with partners and ensuring process consistency with GDS standards.
Qualifications Education / Languages
* Healthcare 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 or Clinical Trial Safety Management.
* Experience leading or participating in Drug Safety Monitoring Committee meetings.
* Experience with ICF drafting and usage.
* Strong understanding of drug safety regulations.
* 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’ve built a diverse culture that rewards high performance and nurtures talent. ICON offers a competitive salary and benefits focused on well-being and work-life balance, including:
* Annual leave entitlements.
* Health insurance options.
* Retirement planning options.
* Global Employee Assistance Programme via TELUS Health.
* Life assurance.
* Optional benefits like childcare vouchers, bike schemes, gym discounts, travel passes, health assessments.
Visit our careers website to learn more about working at ICON.
ICON is an equal opportunity employer committed to a discrimination-free workplace. Qualified applicants will receive consideration regardless of race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.
If you need reasonable accommodation due to a medical condition or disability during the application process or to perform essential job functions, please let us know or submit a request.
If you are interested but unsure if you meet all requirements, we encourage you to apply. You might be exactly what we are looking for!
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