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. This involves defining process KPIs, monitoring performance, and driving continuous improvement. Ensuring vendor compliance with sponsor requirements in clinical trials and post-authorization studies is also key.
The Manager Clinical Safety Operations is responsible and accountable for:
1. Managing processes for medical safety follow-up queries for ICSRs from clinical trials and post-authorization studies, including SAE reconciliation activities.
2. Reconciliation of ICSRs exchanged with partners and other sources.
3. Maintaining the study protocol library and product dictionary in the safety database.
4. Reviewing safety sections of trial documents.
5. Contributing to trial resource and budget planning.
6. Implementing clinical trial safety activities in collaboration with partners and aligning safety management processes with GDS standards.
Qualifications
Education / Languages: Healthcare Professional with extensive experience in pharmacovigilance, clinical development, project management, and IT systems. Fluent in English. A university degree or relevant professional experience is required.
Professional Experience: 5-7 years in Drug Safety or Clinical Trial Safety Management. Experience leading or participating in Drug Safety Monitoring Committees. Skills in drafting and using ICFs. Strong understanding of drug safety regulations. Excellent communication skills and intercultural experience in matrix teams.
What ICON can offer you
We prioritize building a diverse culture that rewards high performance and nurtures talent. Our benefits include competitive salary, health insurance, retirement plans, annual leave, and various optional benefits like childcare vouchers, gym discounts, and more. We also offer a global Employee Assistance Programme supporting your well-being.
ICON is an equal opportunity employer committed to a workplace free of discrimination. If you need accommodations during the application process due to a disability or medical condition, please let us know. We encourage all qualified candidates to apply, even if they do not meet every requirement.
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