Drug Safety Physician, EMEA (HQ), Anywhere Europe - Home Based

We are searching for a Drug Safety Physician for Medical Review Services across the EMEA region for an exciting molecule in clinical development that has a breakthrough mechanism of action for patients suffering from a CNS disease. In this position you would work closely with the Global HQ for the EMEA region and ensure oversight of the emerging safety profile of the product, including medical review of individual case safety reports, signal detection / evaluation, safety reporting, risk-benefit evaluation, and risk management.

About ICON:

At ICON, it’s our people that set us apart. Our diverse teams enable us to become a better partner to our customers and help us to fulfil our mission to advance and improve patients’ lives. Our ‘Own It’ culture is driven by four key values that bring us together as individuals and set us apart as an organization: Accountability & Delivery, Collaboration, Partnership and Integrity. We want to be the Clinical Research Organization that delivers excellence to our clients and to patients at every touch-point. In short, to be the partner of choice in drug development. That’s our vision. We’re driven by it. And we need talented people who share it. If you’re as driven as we are, join us. You’ll be working in a dynamic and supportive environment, with some of the brightest and the friendliest people in the sector, and you’ll be helping shape an industry.

• ensure oversight of the emerging safety profile of the product, including medical review of individual case safety reports as required, signal detection and evaluation, periodic safety reporting, risk-benefit evaluation, and risk management throughout the lifecycle of the product
• ensure that safety signals are identified promptly and communicated/escalated within the company appropriately
• ensure high quality medical safety contributions to Pharmacovigilance Advisory Board (PVAB)
• develop medical safety strategic contributions to other R&D governance bodies and review committees (e.g., DSC, MSEB, GMDB)
• deliver safety input into submission documents such as Integrated Summary of Safety, Clinical Summary of Safety (Module 2.7.4), Clinical Overview (Module 2.5) as well as safety update reports
• support preparation of regulatory authority meetings, interactions with external advisers or opinion leaders, effective collaboration with colleagues from partnership companies for co-development or co-marketing
• maintain a high level of knowledge about the product and the therapeutic area

Necessary professional experience:
• Clinical experience (preferably ≥ 2 years) as a physician
• Industry experience (preferably ≥ 5 years) mainly in the field of pharmacovigilance
• Good understanding of product development process and some experience of cross-functional teamwork
• Excellent knowledge of pharmacovigilance regulations/guidelines and its application for activities related to assigned product/s throughout the product lifecycle
• Knowledge of aggregate data analytics and understanding of related sciences such as predictive modelling, epidemiology, health outcomes and biostatistics

Required technical skills:
• Good medical judgement in medical safety decision making
• Ability to author moderately complex benefit-risk related reports and other safety submission documents.
• In close collaboration with the global Safety Strategy Lead, contributes to scientifically grounded discussions to support the safety strategy, in the course of clinical development interactions and submissions
• Ability to conduct aggregate evaluation with multiple sources by applying and demonstrating efficiency from processes and tools
• Ability to ensure projects are completed within prescribed timelines

Required personal skills:
• Strong team player
• Solution and results oriented
• Ability to work in intense, fast-paced, multi-national environment, to cope with resistance and solve problems
• Demonstrated ability to work under pressure, to achieve strict timeline targets and to lead through complex situations

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, please let us know.

Would you like to know more? Please contact the lead recruiter, michael.kellitt@docsglobal.com

We are looking forward to your application!

Michael Kellitt

Senior Recruitment Consultant DACH
+49 173 170 2681
michael.kellitt@docsglobal.com