Senior Drug Safety Associate
見る: 162
更新日: 22-10-2024
場所: Cologne North Rhine-Westphalia
業界: Gesundheitswesen
ジョブタイプ: Festanstellung
仕事内容
Senior Drug Safety Associate - Germany - remote or office based
ICON plc is a world-leading healthcare intelligence and clinical research organisation. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organisations.
With our patients at the centre of all that we do, we help to accelerate the development of drugs and devices that save lives and improve quality of life.
Our people are our greatest strength, are at the core of our culture, and the driving force behind our success. ICON people have a mission to succeed and a passion that ensures what we do, we do well.
As a Senior Drug Safety Associate at ICON, you’ll work within a large-scale, fast-paced environment. As part of our Safety Reporting Group in ICON, our DSA’s contribute to our culture of process improvement, perform expedited and periodic safety reporting, maintain projects and liaise with Sponsors, ICON project managers and investigational sites as required. We pride ourselves on our amazing company culture, where we work as one team to achieve industry-leading results.
The Role:
As a Snr DSA, you will be expected to prepare regulatory documentation packets and coordinate the timely completion and submission of required reports to Health Authorities, Ethic Committees, Principal Investigators and business partners.- Ensure compliance with regulatory reporting requirements for safety reporting in clinical trials.
- Ensure all ICON, Sponsor, and regulatory timeframes are met for the reporting of safety information.
- Ensure the completion of all departmental project activities accurately in accordance with ICON standards, regulatory requirements, and contractual obligations to sponsors
To be successful in the role, you will have:
The successful candidate will have relevant clinical research/pharmaceutical industry experience, preferably in pharmacovigilance/drug safety, with knowledge of medical terminology and coding systems.- Must be fluent in written and verbal local language with good communication skills and basic computer skills. Detail orientated and capable of working effectively within a team environment.
- Medical/science background and/or bachelor’s degree or local equivalent.
Benefits of Working in ICON:
Our success depends on the knowledge, capabilities and quality of our people. That’s why we are committed to developing our employees in a continuous learning culture - one where we challenge you with engaging work and where every experience adds to your professional development.
At ICON, our focus is to provide you with a comprehensive and competitive total reward package that comprises, not only an excellent level of base pay, but also a wide range of variable pay and recognition programs. In addition, our best in class employee benefits, supportive policies and wellbeing initiatives are tailored to support you and your family at all stages of your career - both now, and into the future.
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, color, 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
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締切: 06-12-2024
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