Safety Lead
UCB – Inspired by patients. Driven by science.
Help us transform patients’ lives.

About UCB

At UCB, we put our heart, soul and skills into making a difference for people living with severe diseases. We look to transform patients’ lives by pushing the boundaries of what is possible. With us, our talent makes the most of who they are, unlocking innovation and setting new standards for patients.

Everything we do starts with a simple question: “How will this make a difference to the lives of people living with severe diseases?” And to find the answers, we connect globally with patients and their families living with the physical and social burdens of severe disease. These connections give us new perspectives, drive our innovation, and offer a hope for a new generation of therapies that will help to transform lives.

To strengthen our Patient Safety Group, we are looking to fill the position of: Safety Lead.

About the Role
You will be responsible for:

• Overall safety risk management of assigned projects, realized through leadership of the Benefit-Risk Team, ensuring adequate cross-functional input.
• Developing core safety strategy and appropriate safety positions on benefit-risk matters, presenting and defending these positions to internal and external stakeholders.
• Leading the combined (clinical study and post marketing sources) Safety Signal Detection for assigned projects.
• Leading the effort within Patient Safety, cross-functionally and with vendors to ensure PST/PVU deliverables are met, and ensure issues and challenges including benefit-risk changes are known.
• Leading the development and maintenance of the Benefit Risk Assessment, SRMS and other safety driven documents and ensuring that changes to the assessment are followed by appropriate actions to be proposed to the PST/PVU.
• Ensuring compliance with global regulations and ICH guidelines regarding the preparation of required regulatory expedited and periodic reports, in collaboration with other Patient Safety teams.
• Preparing, reviewing, and approving of product safety information in all ad hoc documents, investigator brochure or regulatory-required periodic reports requiring medical review and interpretation.  

About You
You should have/be:

• Several years pharmaceutical industry experience with a proven and successful track record in scientific and project team leadership.
• An understanding of the global pharmacovigilance and safety requirements from non-clinical development through the registration process and onto the market, ideally.
• An effective Team Leader of a team of highly qualified individual contributors.
• The ability to act without oversight in most circumstances and can provide key input to difficult projects.
• Technical expertise in pharmacovigilance and clinical safety coupled with a broad global knowledge of industry trends and best practices.
• Knowledge of relevant concepts in health care, human biology, data management and systems, epidemiology, pharmacology, pharmacovigilance, drug development and statistics.

About UCB
UCB, Brussels, Belgium (www.ucb.com) is a global biopharmaceutical company focused on the discovery and development of innovative medicines and solutions to transform the lives of people living with severe diseases of the immune system or of the central nervous system. With 7 500 people in approximately 40 countries, the company generated revenue of € 4.6 billion in 2018. UCB is listed on Euronext Brussels (symbol: UCB). Follow us on Twitter: @UCB_news