- 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 IM P/ 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 of clinical trial safety related activities in the alliance with relevant partners/service providers of sponsor and alignment of guidelines and processes related to clinical trial safety management with existing GDS processes
- Health Care Professional with extensive work experience in pharmacovigilance area, clinical development, project management, 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
- 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
- Various annual leave entitlements
- A range of health insurance offerings to suit you and your family's needs
- Competitive retirement planning offerings to maximise savings and plan with confidence for the years ahead
- Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family's well-being
- Life assurance
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Drug Safety Manager - Leipzig, Deutschland - ICON Strategic Solutions
Beschreibung
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.
What you will be doing:
The role of the Drug Safety Manager 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 Drug Safety Manager is accountable for the development, optimization, implementation, and documentation of appropriate 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 noninterventional post authorization studies in close collaboration with the Vendor Manager
The Drug Safety Manager is responsible and accountable for:
You possess:
Education/Languages
Professional Experience
What ICON can offer you:
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. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.
Our benefits examples include:
Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others Visit our careers website to read more about the benefits of working at ICON:
ICON, including subsidiaries, is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, colour, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request here.
Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there's every chance you're exactly what we're looking for here at ICON whether it is for this or other roles.
