Ref #: 34181

Employment type: Permanent - Full-Time

Location: Home based in Europe

Posted: 14-Jan-2022

Description

Roles & Responsibilities of the position:

• ensure the delivery of integrated medical safety strategies for assigned development compound(s) and/or marketed product(s)
• proactive safety surveillance and effective signal and benefit-risk management
• set the medical safety strategic direction
• delivering the benefit-risk profile
• provide clear, strong and visible safety scientific leadership
• ensure oversight of the emerging safety profile of the product
• 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


Job Requirements:

• Physician with broad clinical experience
• Several years of medical experience as a physician, preferably clinical
• Broad industry experience , preferably including both clinical development and pharmacovigilance experience; excellent knowledge of the pharmacovigilance regulations/guidelines and its application for activities related to assigned product/s
• Excellent knowledge of product development process and experience of cross-functional teamwork
• Preferentially prior experience with NDA/BLA or equivalent regulatory submissions or working experience from a Regulatory Agency on reviewing submission files
• First-hand experience in handling safety issues related to known target organ toxicities (e.g. hepatic, renal, hematological) and good medical understanding of the relevant therapeutic area(s)
• Expert knowledge of aggregate data analytics and understanding of related sciences such as predictive modelling, epidemiology, health outcomes and biostatistics
• Professional experience in a global matrix environment across regions



To apply:
Would you like to know more? We are looking forward to your application by either submitting your CV via email to anja.potrafke@docsglobal.com or apply via our career portal on www.docsglobal.com. We are looking forward to hearing from you.


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.